Academic literature on the topic 'Stability indicating assay method'
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Journal articles on the topic "Stability indicating assay method"
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Thoppil, Simmy O., and P. D. Amin. "Trimetazidine: stability indicating RPLC assay method." Journal of Pharmaceutical and Biomedical Analysis 25, no. 2 (2001): 191–95. http://dx.doi.org/10.1016/s0731-7085(00)00483-0.
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Rajadhyaksha, Namita S., Satish P. Jain, and Purnima D. Amin. "Carbamazepine: Stability Indicating HPLC Assay Method." Analytical Letters 40, no. 13 (2007): 2506–14. http://dx.doi.org/10.1080/00032710701583557.
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Al-Masri, R., and M. Al-Mardini. "STABILITY-INDICATING HPLC ASSAY METHOD OF LOVASTATIN." Bulletin of Pharmaceutical Sciences. Assiut 28, no. 2 (2005): 185–89. http://dx.doi.org/10.21608/bfsa.2005.65287.
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Garcia, Cássia V. "Stability-Indicating HPLC Method for Posaconazole Bulk Assay." Scientia Pharmaceutica 80, no. 2 (2012): 317–27. http://dx.doi.org/10.3797/scipharm.1111-11.
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Sangeetha, M., Tirumala ., and Nagamallika . "STABILITY INDICATING RP-LC ASSAY METHOD FOR CARISOPRODOL." International Journal of Current Pharmaceutical Research 9, no. 6 (2017): 79. http://dx.doi.org/10.22159/ijcpr.2017v9i6.23434.
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Objective: A reverse phase stability-indicating HPLC method was developed for the determination of Carisoprodol in pharmaceutical dosage forms. The chromatographic elution was achieved on C18, 250 mm × 4.6 mm, 5-μm particle size column.Methods: The mobile phase contains a mixture of water and acetonitrile in ratio of 60:40 v/v. The flow rate was 1.0 ml min-1 and was detected by Refractive index detector.Results: The method was proven to be linear over a range of 1 to 4 mg/ml with a mean correlation coefficient of 0.99998. The %mean recovery is in the range of 100.55% to 101.11% and %RSD was less than 1.0% between preparations. The % RSD for Assay results of initial sample preparation in different intervals of 0hr, 24 h, 30 h and 48 h was less than 1.0%. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from Carisoprodol.Conclusion: The developed method was validated as per international ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.
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Saravanan, G., B. M. Rao, M. Ravikumar, M. V. Suryanarayana, N. Someswararao, and P. V. R. Acharyulu. "A Stability-Indicating LC Assay Method for Bicalutamide." Chromatographia 66, no. 3-4 (2007): 219–22. http://dx.doi.org/10.1365/s10337-007-0280-0.
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Desai, Namita D., Pirthipal P. Singh, Purnima D. Amin, and Satishkumar P. Jain. "Stability-Indicating LC Method for Assay of Cholecalciferol." Chromatographia 69, no. 3-4 (2008): 385–88. http://dx.doi.org/10.1365/s10337-008-0914-x.
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Rao, B. Mallikarjuna, Arpita Chakraborty, M. K. Srinivasu, et al. "A stability-indicating HPLC assay method for docetaxel." Journal of Pharmaceutical and Biomedical Analysis 41, no. 2 (2006): 676–81. http://dx.doi.org/10.1016/j.jpba.2006.01.011.
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Hou, Shuguang, Michael Hindle, and Peter R. Byron. "A stability-indicating HPLC assay method for budesonide." Journal of Pharmaceutical and Biomedical Analysis 24, no. 3 (2001): 371–80. http://dx.doi.org/10.1016/s0731-7085(00)00424-6.
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Alam, Prawez, Faiyaz Shakeel, Mohammed H. Alqarni, et al. "Development and Validation of A Stability-Indicating Greener HPTLC Method for the Estimation of Flufenamic Acid." Separations 10, no. 1 (2023): 39. http://dx.doi.org/10.3390/separations10010039.
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The literature on ecofriendly/greener high-performance thin-layer chromatographic (HPTLC) methods for quantifying flufenamic acid (FFA) is scant. In order to develop and validate a stability-indicating greener HPTLC densitometry assay for FFA determination in marketed products, this research was conducted. The ecofriendly eluent system was composed of ethanol–water (70:30 v/v). FFA was measured at 290 nm of wavelength. The greenness scale of suggested analytical assay was derived using “Analytical GREENness (AGREE)” methodology. The suggested stability-indicating HPTLC assay was linear for FFA determination in 25–1400 ng/band range with a determination coefficient of 0.9974. The suggested analytical assay for FFA analysis was simple, rapid, accurate, precise, robust, selective, stability-indicating, and greener. The AGREE scale for the developed stability-indicating HPTLC assay was derived to be 0.77 utilizing AGREE methodology, indicating an outstanding greenness characteristic of the suggested densitometry technique. The ecofriendly HPTLC technique was able to detect FFA degradation product under forced degradation studies, indicating its stability-indication characteristics and selectivity. The amount of FFA in marketed tablets brand A and B was determined to be 101.28 and 99.17%, respectively, indicating the suitability of the suggested analytical technique in the assay of FFA in marketed products. These results indicated that FFA in marketed products may be routinely measured using the stability-indicating greener HPTLC technique.
Dissertations / Theses on the topic "Stability indicating assay method"
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Kirk, Loren Madden, and Stacy D. Brown. "Beyond-Use Date Determination of Buprenorphine Buccal Solution Using a Stability-Indicating High-Performance Liquid Chromatographic Assay." Digital Commons @ East Tennessee State University, 2015. https://dc.etsu.edu/etsu-works/5305.
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Objectives
The objectives of this study included developing and validating a stability-indicating high-performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection for the determination of buprenorphine in a buccal solution for veterinary use, and applying that method to determine the stability of a 3 mg/ml buprenorphine preparation in room temperature and refrigerated storage conditions. This preparation, intended for buccal administration in feline patients, plays an important role in pain management in cats.
Methods
A stability-indicating HPLC method was developed and validated for system suitability, accuracy, repeatability, intermediate precision, specificity, linearity and robustness based on US Pharmacopeia (USP) General Chapter. The method was then applied to the study of potency changes over 90 days in a buccal buprenorphine solution stored at two temperatures.
Results
All HPLC-UV method data met acceptable criteria for the quantification of buprenorphine in a buccal solution formulation. The buprenorphine concentrations found in each stability sample remained within the 90–110% of label claim throughout the 90 days of study. All stability test bottles of the buprenorphine buccal solution retained their original appearance. For the room temperature bottles, some white particulate matter was noted in the threads of the container bottles starting at day 21. The pH of the preparations during the course of the study was in the range of 3.57–4.06 and 4.01–4.16 for the room temperature and refrigerated samples, respectively.
Conclusions and Relevance
Pharmacists have compounded a concentrated 3 mg/ml buccal solution to use easily in the home care or outpatient setting for treatment of feline pain. Prior to this investigation, pharmacists empirically assigned beyond-use dates to this formulation based on standards in USP General ChapterPharmaceutical Compounding – Nonsterile Preparations. This study of a 3 mg/ml buprenorphine buccal solution indicates stability through 90 days.
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Van, den Berg Elaine. "Development of a stability indicating HPLC method for the Pheroid™ delivery system / Elaine van den Berg." Thesis, North-West University, 2010. http://hdl.handle.net/10394/5105.
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Stability plays an important role in the development of a new drug product. High Performance Liquid Chromatography (HPLC) is considered a stability indicating method of analysis. It is widely used in the pharmaceutical industry for the quantification of small organic molecules during stability testing.
Previous stability studies conducted on Pheroid™-based drug products, experienced problems with the generation of reliable data by means of HPLC analysis. With these studies it was concluded that the inconclusive results could either be attributed to the stability of the delivery system itself and the compatibility of the active pharmaceutical ingredients (API's) with the delivery system, or to the usage of unsuitable HPLC methods. The aims of this study were to:
i. determine if the Pheroid™ delivery system changes significantly over time at
accelerated storage conditions and how these changes influence the HPLC
analysis,
ii. determine the effect of the anti-oxidant tert-butylhydroquinone (TBHQ) on the
stability and HPLC analysis of the Pheroid™ delivery system, and
iii. to suggest a suitable approach for the analysis of Pheroid™-based drug products.
Pheroid™ microsponges, containing no API's, were prepared and stored for a period of three months at 5°C, 25°C+60%RH, 30°C+65%RH and 40°C+75%RH. Two of the four Pheroid™ formulations contained an extra anti-oxidant, namely TBHQ. Monthly HPLC analyses were done using existing methods for mefloquine and artesunate. In addition to HPLC analysis, particle size analysis and Confocal Laser Scanning Microscopy (CLSM) were undertaken to support the HPLC results and provide information concerning the overall stability of the Pheroid™ delivery system.
After the completion of the above analyses, experiments were carried out to determine whether adjustments to some of the key chromatographic parameters could improve the separation of Pheroid™-based samples. The parameters that were subjected to change included the organic solvent, isocratic versus gradient separation, pH and detection wavelength. Two pro-Pheroid vesicles formulations were prepared and stored for a three month period at 40°C+75%RH only. No API was added to the one formulation while the other contained 2 mg/ml of mefloquine hydrochloride.
Results obtained indicated that the Pheroid™ formulations changed after exposure to elevated temperature and humidity. The number of detectable peaks increased, longer run times became necessary and solubility in the sample solvent (methanol) decreased. Solubility of the Pheroid™ formulations in methanol was preserved to some extent by the presence of TBHQ. Physical signs of instability like discolouration and creaming were noted for TBHQ-containing formulations. TBHQ also seemed to have influenced the particle sizes, particle size distributions and structure of the Pheroid™ microsponges.
With adjustments made to the HPLC method it was found that:
i. the sample solvent is incompatible with the HPLC system,
ii. very hydrophobic compounds are present in the Pheroid™-based samples,
iii. acetontrile and methanol are unsuitable for both gradient and isocratic separation of Pheroid™-based samples,
iv. more Pheroid™ components absorb at shorter wavelengths, and
v. small changes in the pH values usually implemented do not influence the
retention and selectivity of the Pheroid™ components. The Pheroid™ delivery system proved to be too complex and reversed hydrophobic for phase HPLC analysis. Preparation of the sample by only diluting the Pheroid™ formulations with pure methanol was not optimal. These samples introduced compounds to the column of which some caused interferences with the analyte peak while others were difficult to elute from the column. To continue using HPLC for the analysis of Pheroid™-based drug products, it is therefore recommended that attention should be given to the development of a more appropriate sample preparation procedure, like solid phase extraction or liquid-liquid extraction, one that will eliminate the effects of the Pheroid™ components. Physical instabilities noticed with the addition of TBHQ, suggest that there should also be attended to the compatibility and stability of each of the components in the Pheroid™ delivery system during formulation development.<br>Thesis (M.Sc. (Pharmaceutics))--North-West University, Potchefstroom Campus, 2010.
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SANTOS, Bruno Aires dos. "Desenvolvimento e Validação de Método Indicativo de Estabilidades Para Comprimidos Revestidos de Metildopa." Universidade Federal de Pernambuco, 2014. https://repositorio.ufpe.br/handle/123456789/17159.
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Previous issue date: 2014-05-30<br>A metildopa (a-metil-3, 4-dighidro-l-fenilalanina) é um agente hipotensor de ação central, é uma pró-droga, que exerce sua ação anti-hipertensiva através de um metabólito ativo. A estabilidade é um importante parâmetro para avaliar a segurança, eficácia e qualidade exigidas para o registro sanitário de produtos farmacêuticos. Vários países publicam diretrizes para estabilidade farmacêutica. No Brasil, estes estudos devem ser conduzidos segundo o Guia para a Realização de Estudos de Estabilidade, publicada na resolução - RE n.01 de 29 de julho de 2005 e a RDC 58 de 20 de dezembro de 2013 que estabelece parâmetros para a notificação, identificação e qualificação de produtos de degradação em medicamentos com substâncias ativas sintéticas e semissintéticas, classificados como novos, genéricos e similares e dá outras providências. O objetivo desse trabalho foi desenvolver um método indicativo de estabilidade para comprimidos revestidos de metildopa 500mg, avaliando a especificidade e a seletividade deste método. Para avaliação da especificidade e seletividade do método foram mantidas amostras da metildopa matéria-prima, comprimido revestido 500mg e placebo nas seguintes condições de estresse: hidrólises (ácida, básica e neutra), oxidação e temperatura; as amostras também foram submetidas ao teste de fotoestabilidade. A seletividade do método também foi demonstrada após realização de testes com o padrão primário de metildopa contaminado com a impureza 3-O-metil-metildopa. Os resultados foram analisados segundo dados gerados por cromatografia líquida de alta eficiência (CLAE) com detector de arranjo de diodos (DAD). A 3-O-metildopa apresenta tempo de retenção relativo (TRR) de 1,37 frente à metildopa. A metildopa mostrou-se estável nas hidrólises neutras e ácida menos concentradas bem como na degradação térmica, oxidativa e na fotoestabilidade. Apresentou um decaimento muito acentuado nas condições básicas (NaOH 0,1 e 1,0M), sendo inadequado para o estudo de métodos indicativos de estabilidade como indica a RDC 58 de 2013. A condição mais severa da hidrolise ácida (HCl 5,0M) apresentou um teor de 77,80% para a matéria-prima e 82,99% para o comprimido revestido em comparação com o padrão de trabalho após 72 horas de estudo, ambos apresentaram um pico de degradação com TRR de aproximadamente 2,00. Na condição de hidrólise alcalina menos concentrada (NaOH 0,01M) apareceram produtos de degradação tanto na matéria-prima como para o comprimido revestido de metildopa, porém, o pico que apresenta área significativa apresenta TRR de 0.38 e o teor do fármaco foi de 73,49% para a matéria-prima e 74,48% para o comprimido revestido em comparação com o padrão de trabalho após 72 horas de estudo. Através das análises dos resultados obtidos utilizando as ferramentas de integração e de análise espectral para avaliação da similaridade e pureza dos picos, verifica-se que o método utilizado consegue detectar os produtos de degradação que venham a surgir durante os estudos de estabilidade. O método posteriormente foi validado utilizando como referências a RE 899 de 2003 e a norma técnica da ICH Q2 R1. O método desenvolvido e validado foi utilizado no estudo de estabilidade de um comprimido revestido de metildopa 500mg similar constante no mercado brasileiro, apresentando resultados dentro da especificação exigida para o produto.<br>Methyldopa (a-methyl-3,4-dihydro-l-phenylalanine) is a centrally acting antihypertensive agent, is a prodrug, which exerts its antihypertensive action through an active metabolite. Stability is an important parameter to evaluate the safety, efficacy and quality required for sanitary registration of pharmaceutical products. Several countries publish guidelines for pharmaceutical stability. In Brazil, the stability studies should be conducted according to the guide on conducting stability studies, published in the resolution RE 01 of July 29, 2005 and RDC 58 of December 20, 2013 laying down parameters for notification, identification and qualification of degradation products in medicine with synthetic and semi synthetic active substances classified as new, generic and similar and other measures. The aim of this study was to develop a stability indicating method for coated tablets 500mg of methyldopa following and evaluating the specificity and selectivity of this method. To assess the specificity and selectivity of the method of methyldopa samples were stored raw material, coated tablet 500mg and placebo in the following stress conditions: hydrolysis (acidic, basic and neutral), oxidation, light and temperature. The selectivity of the method was demonstrated after testing with the primary pattern methyldopa contaminated with impurity 3-O-methyl-methyldopa. The results were analyzed according to data generated by high performance liquid chromatography (HPLC) with diode array detector (DAD). 3-O-methyl-methyldopa has RRT 1.37 front methyldopa. Methyldopa was stable in neutral and acidic hydrolysis less concentrated as well as thermal, oxidative degradation and photostability. Showed a dramatic decay in basic conditions (NaOH 0,1 and 1,0M) and unsuitable for the study of stability indicating methods as shown in the RDC 58/ 2013. The most severe conditions of acid hydrolysis (5,0M HCl) showed a content of 77.80 % for the raw material and 82.99 % for the coated tablet compared the standard of work after 72 hours of study, both showed a peak of degradation with TRR approximately 2,00. In the condition of less concentrated alkaline hydrolysis (0,01M NaOH) appeared both in the degradation products as raw material for the coated tablet methyldopa, however, the peak that shows significant area RRT 0,38 and shows content of the drug was 73,49% for raw and 74,48% for the coated tablet compared the standard of work after 72 hours of study. Through the analysis of the results obtained using the tools of integration and spectral analysis for assessing similarity and purity of the peaks, it is found that the method can detect possible degradation products that arise during the stability studies . The method was subsequently validated using as references to RE 899 2003 and the technical standards of the ICH Q2 R1. The developed and validated method was used on a tablet stability study coated methyldopa 500mg similar constant in the Brazilian market, presenting results within the specification required for the product.
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Souza, Aline de. "Desenvolvimento de metodologias indicativas de estabilidade para medicamentos utilizados como diuréticos." Universidade de São Paulo, 2015. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-15122015-084128/.
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Os diuréticos aumentam o fluxo urinário e a excreção de sódio e são utilizados para ajustar o volume e/ou a composição dos líquidos corporais em uma variedade de situações clínicas. A furosemida é um agente diurético potente que induz uma poderosa diurese. É utilizada no tratamento de edema associado com o coração e doenças renais. Nesta pesquisa objetivou-se desenvolver métodos indicativos de estabilidade para a furosemida, por eletroforese capilar em solução livre (FSCE) e cromatografia liquida de alta eficiência (CLAE). O método por FSCE utilizou um capilar de sílica fundida com comprimento total de 30,2 cm x 50,0 µm d.i. O tampão utilizado foi tetraborato de sódio 2,0 mmol L-1 e 10% de metanol, injeção hidrodinâmica 0,5 psi/5s, tensão aplicada +25 kV, detecção em 273 nm e temperatura a 25ºC. O tempo de migração da furosemida foi de 1,8 minutos. O método obteve boa linearidade no intervalo de 70,0 a 130,0 µg.mL-1 com coeficiente de correlação maior de 0,99. Os limites de detecção e de quantificação foram 6,2 µg.mL-1 e 20,6 µg.mL-1, respectivamente. A precisão do sistema foi inferior a 2,0%. A repetibilidade e precisão intermediária foram inferiores a 5,0%. A recuperação média foi de 102,1 %. No teste de especificidade, foram detectados três potenciais produtos de degradação com os seguintes tempos de retenção 1,3 2,0 e 2,2 min. O método por CLAE utilizou uma coluna Shim-pack CLC-ODS(M)® (250mm x4.6mm, 5µm). A fase móvel era constituída de acetonitrila:água (50:50) com 0,1% de ácido fórmico. O fluxo foi de 1.0 mL min-1 e detecção em 273 nm e temperatura a 30 ± 1 ºC. O método apresentou boa linearidade nas concentrações entre 7,0 e 13 µg.mL-1; com coeficiente de correlação maior de 0,99. E tempo de retenção para furosemida foi de 4,9 minutos. Os limites de detecção e de quantificação foram 0,6 µg.mL-1 e 1,9 µg.mL-1, respectivamente. A precisão do sistema foi inferior a 1,0%. A repetibilidade e precisão intermediária foram inferiores a 3,0%. A recuperação média foi de 105,1 %. No teste de especificidade, foram detectados três potenciais produtos de degradação com os seguintes tempos de retenção 2,4, 3,1 e 3,8 min.<br>Diuretics increase urine flow and sodium excretion and are used to adjust volume and / or composition of body fluids in a variety of clinical situations. Furosemide is a potent diuretic agent that induces a strong diuresis. It is used in the treatment of edema associated with heart and kidney disease. This research aimed to develop stability indicative methods for furosemide, by capillary electrophoresis in free solution (FSCE) and high-performance liquid chromatography (HPLC). The method FSCE used a fused silica capillary with a total length of 30.2 cm x 50.0 um di The buffer used was sodium tetraborate 2.0 mmol L-1 and 10% methanol, hydrodynamic injection 0.5 psi / 5s, +25 kV applied voltage, detection at 273 nm and 25 °C. The furosemide migration time was 1.8 minutes. The method achieved good linearity in the range of 70.0 to 130.0 µg.mL-1 with correlation coefficient higher of 0.99. The limits of detection and quantification were 6.2 and 20.6 µg.mL-1 µg.mL-1, respectively. The system accuracy was less than 2.0%. The repeatability and intermediate precision were less than 5.0%. The average recovery was 102.1%. The specificity test detected three potential degradation products with the following retention times 1.3, 2.0 and 2.2 min. The HPLC method used a Shim-pack CLC-ODS (M)® column (250mm x 4.6mm, 5µm). The mobile phase consisted of acetonitrile: water (50:50) with 0.1% formic acid. The flow rate was 1.0 mL min-1, detection at 273 nm and temperature at 30 ± 1°C. The method showed good linearity in concentrations between 7.0 and 13.0 µg.mL-1; with correlation coefficient higher of 0.99. Retention time for furosemide was 4.9 minutes. The limits of detection and quantification were 0.6 µg.mL-1 and 1.9 µg.mL-1, respectively. The system accuracy was less than 1.0%. The repeatability and intermediate precision were less than 3.0%. The average recovery was 105.1%. The specificity test detected three potential degradation products of the following retention times of 2.4, 3.1 and 3.8 min.
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Galdos, Angel Arturo Gaona. "Desenvolvimento de metodologias indicativas de estabilidade para medicamentos que atuam no diabetes mellitus tipo II." Universidade de São Paulo, 2012. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-04042013-092152/.
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O diabetes mellitus (DM) é uma síndrome na qual o metabolismo de hidratos de carbono, gorduras e proteínas está alterado, por falta de secreção de insulina ou por diminuição da sensibilidade tissular a este hormônio. O DM pode ser do tipo I, também denominado diabetes mellitus insulinodependente (DMID), caracterizado pela falta de secreção da insulina, e do tipo II, também denominado diabetes mellitus não insulinodependente (DMNID), caracterizado pela menor sensibilidade dos tecidos efetores às ações metabólicas da insulina. Embora ainda não haja cura definitiva, há vários tratamentos disponíveis que proporcionam qualidade de vida para o paciente portador, como a administração de hipoglicemiantes orais. Nesta pesquisa, objetivou-se desenvolver métodos indicativos de estabilidade para a glibenclamida e o cloridrato de metformina. Assim, foram desenvolvidos métodos de rastreamento ortogonais utilizando a cromatografia líquida de alta eficiência (HPLC) e a eletroforese capilar (CE), metodologias que foram desafiadas com os estudos da degradação forçada. Realizou-se, também, a identificação do principal produto de degradação da glibenclamida utilizando a cromatografia líquida acoplada à espectrometria de massa (LC-MS). O método por HPLC teve o melhor desempenho no monitoramento dos produtos de degradação da glibenclamida, apresentando boa linearidade nas concentrações entre 0,210 e 0,360 mg/mL; com coeficiente de correlação maior de 0,99. A precisão calculada como desvio padrão relativo (DPR) foi menor de 3%, exatidão do método comprovada mediante teste de recuperação, obtendo-se valores de 100±3,0%. No teste de especificidade, foram detectados três potenciais produtos de degradação, com os seguintes tempos de retenção relativos (TRR) de 0,33; 0,46 e 0,83. O método CZE teve o melhor desempenho no monitoramento dos produtos de degradação do cloridrato de metformina, apresentando boa linearidade nas concentrações entre 0,210 e 0,360 mg/mL, com coeficiente de correlação maior de 0,99. A precisão, calculada como DPR, foi menor do que 5%, exatidão do método comprovada mediante o teste de recuperação, obtendo-se valores de 100±3,5%. No teste de especificidade, foram detectados cinco potenciais produtos de degradação com os seguintes TRRs de 0,90; 1,14; 1,35; 1,45 e 1,56.<br>Diabetes mellitus (DM) is a syndrome which alters the metabolism of carbohydrates, fats and proteins by lack of insulin secretion or a decrease in tissue sensitivity to insulin. Type 1 DM is also known as insulin-dependent diabetes mellitus is characterized by lack of insulin secretion. The second type of diabetes known as Type II, also called non-insulin dependent, is characterized by the reduced sensitivity of target tissues to the metabolic actions of insulin. Although there is no definitive cure, there are several treatments available that provide quality of life for the patient how treatment with oral hypoglycemic agents. This study had as objective to developed stability-indicating methods for glibenclamide and metformin hydrochloride. Thus, the techniques used in this study involved high performance liquid chromatography (HPLC) and capillary electrophoresis (CE), and both were challenged with forced degradation studies. The identification of degradation products of glibenclamide was also performed, utilizing the mass spectrometry (MS) technique. However, the HPLC technique had the best performance for monitoring the degradation products of glibenclamide, which showed a good linearity in concentrations between 0.210 - 0.360 mg/ml, with a correlation coefficient greater than 0.99. The precision was calculated as a relative standard deviation (RSD) which was less than 3%; the accuracy of the method calculated as the percent recovery was obtained with the following values: 100 ± 3.0%. On the specificity were detected three potential products of degradation utilizing forced degradation, with the following relative retention times (RRT) 0.33, 0.46 and 0.83. The CZE method had the best performance to monitoring the degradation products of metformin hydrochloride, which showed good linearity of concentrations between 0.210 and 0.360 mg/ml, with a correlation coefficient greater than 0.99. The intra-day and inter-day precision calculated as DPR was less than 5%, and an accuracy of this method was achieved using the values of 100 ± 3.5%. In the specificity were five potential degradation products were detected with the following TRRS: 0.90, 1.14, 1.35, 1.45 and 1.56.
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Maranho, Rafael Finocchiaro. "Desenvolvimento de um método indicativo de estabilidade para ondansetrona." Universidade de São Paulo, 2017. http://www.teses.usp.br/teses/disponiveis/46/46137/tde-14122017-144542/.
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ultravioleta e espectrometria de massas para análise do teor e limite de impurezas e compostos de degradação para o principio ativo farmacêutico ondansetrona e três diferentes formas farmacêuticas foi desenvolvido utilizando conceitos de qualidade analítica por planejamento (aQbD) e validado de acordo com os requerimentos da USP-NF e do ICH. O método desenvolvido apresentou capacidade de separação de vinte compostos detectados nas amostras envolvidas no estudo: o princípio ativo ondansetrona, sete impurezas descritas nos principais compêndios farmacopéicos mundiais (United States Pharmacopeia-National Formulary, European Pharmacopoeia, British Pharmacopoeia e Indian Pharmacopoeia), onze compostos de degradação gerados pelos estudos de estresse e um excipiente. O método final apresentou um tempo de corrida de 14 minutos, com vazão de fase móvel de 0,4 mL/min, detecção de impurezas por ultravioleta a 220 nm e do princípio ativo a 305 nm, com apoio da detecção por espectrometria de massas de alta resolução (QTOF). Em comparação aos métodos requeridos pelas monografias relacionadas à ondansetrona publicadas nos compêndios farmacopéicos citados, o método desenvolvido apresenta uma alternativa eficiente e econômica para a análise de rotina de diferentes formas da matéria-prima ondansetrona (base, cloridrato, diferentes níveis de hidratação) e formas farmacêuticas (comprimidos, comprimidos de desintegração oral e solução injetável), mostrando que a modernização dos métodos cromatográficos, além de garantir a qualidade dos produtos farmacêuticos e promover a saúde da população, tem um impacto relevante na economia da produção e análise de medicamentos e na diminuição do impacto ao meio ambiente<br>An analytical method by ultraperformance liquid chromatography and detection by UV and mass spectrometry for assay and limit test for impurities and degradation compounds for the active pharmaceutical ingredient ondansetron and three different pharmaceutical products was developed using the analytical Quality by Design (aQbD) approach, and was validated according to the USP-NF and ICH requirements. The analytical method was efficient for the separation of twenty different compounds, detected in the samples involved in this study: the active ingredient ondansetron, seven impurities mentioned in the main global pharmacopeial compendia (United States Pharmacopeia-National Formulary, European Pharmacopoeia, British Pharmacopoeia e Indian Pharmacopoeia), eleven degradation compounds detected in the samples from stress studies and one excipient. The final method was composed by a 14 minutes run, using mobile phase flow at 0.4 mL/min, detection by UV at 220 nm for the impurities and degradation compounds and at 305 nm for ondansetron, supported by the high-resolution mass spectrometry detection (QTOF). Comparing the method developed with the chromatographic methods required by the monographs related to ondansetron published in the mentioned pharmacopeial compendia, it represents an efficient and economic alternative to the routine analysis of different ondansetron raw material forms (base, hydrochloride, different hydrates) and pharmaceutical products (tablets, orally disintegrating tablets and injectable), demonstrating the importance of the modernization of analytical procedures, with regard to not only the quality assurance of pharmaceutical products and promotion of public health, but also to the positive impact on the economy and sustainability of the pharmaceutical analysis and manufacturing.
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Christ, Ana Paula. "DESENVOLVIMENTO E VALIDAÇÃO DE MÉTODOS ANALÍTICOS PARA O DOSEAMENTO DE DAPTOMICINA INJETÁVEL." Universidade Federal de Santa Maria, 2013. http://repositorio.ufsm.br/handle/1/5988.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior<br>This work presents the development and validation of analytical methods to assay daptomycin injection. Daptomycin is a drug of a new class of antibiotics, known as cyclic lipopeptides. It was approved in USA in 2003 and in Brazil in 2009. Up to now, there are no reports about methods to assay the drug in pharmaceutical products, both in scientific literature or in official compendia. Methods to identify daptomycin in raw material were realized as solubility, melting point, infrared spectrophotometry (IR), ultraviolet spectrophotometry (UV) and differential scanning calorimetry (DSC) and they showed appropriate results. The following methods to assay daptomycin injection were developed and validated: high performance liquid chromatography (HPLC), microbiological assay (turbidimetric) and UV-spectrophotometry. All of them were validated according current guidelines, by the following parameters: specificity, linearity, precision, accuracy and robustness, being all the requirements met. The mean values of daptomycin assay by the three methods were: 100,23 ± 0,59% (HPLC); 100,96 ± 2,58% (turbidimetric assay) and 98,98 ± 1,35% (UV-spectrophotometry). They were compared by ANOVA, which indicated that HPLC and turbidimetric assay are interchangeable. The stress testing showed that daptomycin is very susceptible to alkaline medium and that the degradation follows first order kinetic, in the conditions adopted. It was found that the degradation product(s) of daptomycin do not have antimicrobial activity. Considering their characteristics, HPLC and turbidimetric assays can be used in routine quality control and in stability studies of daptomycin injection.<br>Este trabalho apresenta o desenvolvimento e validação de métodos analíticos para o doseamento da daptomicina injetável. A daptomicina é um antibiótico pertencente a uma nova classe de antimicrobianos, conhecidos como lipopeptídeos cíclicos. Foi aprovada para comercialização nos Estado Unidos em 2003 e no Brasil em 2009. Até o momento, não foram relatados métodos de quantificação para o fármaco em produtos farmacêuticos, tanto na literatura científica quanto em compêndios oficiais. Foram realizados métodos para a caracterização da matéria-prima como solubilidade, ponto de fusão, espectrofotometria no infravermelho (IV) e na região do ultravioleta (UV) e calorimetria exploratória diferencial (DSC), sendo que os mesmos permitiram a identificação do fármaco na matéria-prima. Os seguintes métodos para análise quantitativa da daptomicina injetável foram desenvolvidos e validados: cromatografia líquida de alta eficiência (CLAE), ensaio microbiológico (método turbidimétrico) e espectrofotometria na região do UV. Todos os métodos foram validados de acordo com as guias vigentes, frente aos parâmetros de especificidade, linearidade, precisão, exatidão e robustez, tendo sido atendidos os requisitos estabelecidos. Os teores médios de daptomicina na formulação em estudo, pelos métodos desenvolvidos (n=12/método) foram: 100,23 ± 0,59% (CLAE); 100,96 ± 2,58% (ensaio microbiológico) e 98,98 ± 1,35% (espectrofotometria no UV). Esses resultados foram comparados pelo teste de ANOVA, que indicou que os métodos de CLAE e microbiológico são intercambiáveis. Pelo estudo de degradação forçada verificou-se que a condição que induz à maior degradação do fármaco é o meio alcalino, sendo que a reação segue cinética de primeira ordem nas condições usadas. Constatou-se ainda que a amostra degradada da daptomicina não tem ação antimicrobiana. Pelas suas características, os métodos de CLAE e microbiológico podem sem usados no controle de qualidade de rotina e em estudos de estabilidade da formulação injetável de daptomicina.
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陳峙瑞. "Ⅰ.Development of Stability-indicating High Performance Liquid Chromatographic Assay Methods of NSAID Drugs--- Tolmetin and Zomepirac II.Photostability study of Tolmetin." Thesis, 2002. http://ndltd.ncl.edu.tw/handle/61997654301686904495.
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碩士<br>台北醫學院<br>藥學研究所<br>90<br>Abstract
Tolmetin (TLM) and Zomepirac (Z) are used as photosensitizing nonsteroidal antiinflammatory drugs (NSAIDs). When TLM and Z were irradiated by a Hanovia 200W high pressure mercury lamp in methanol, a total of 8 photoproducts of TLM; TLM-1 to TLM-8 and 4 photoproducts of Z; Z-1 to Z-4 photoproducts were observed, respectively. Using preparative HPLC, photoproducts were isolated and their chemical structures were elucidated by UV、IR、MS、NMR and LC-MS spectroscopies.
Next, a rapid, sensitive, and accurate stability-indicating high perfor- mance liquid chromatographic assay method for determining the degra- dation of TLM and Z was developed and vali- dated under acidic, basic, or photo-irradiated conditions. The quantitation was monitored with an Inertsil ODS-3V column using a mobile phase of methanol- 0.3%acetic acid = 64:36 (v/v) for TLM and acetonitrile- methanol - 0.3%acetic = 2:64:34(v/v) for Z detector set at 254nm. The related satistics of the developed methods including the system criteria, peak integrity, and resolution among the parent drug and its degradation products were calculated. The C.V.(%) of intraday and interday tests were lower than 2.3% and 4% , respectively. The percent recovery were between 97.14% ~ 101.73 %. Our established HPLC assay method shows good selectivity and specificity which is suitable for the stability measurement of TLM and Z.
The rates of photodegradation between TLM and Z present significant difference, no mater the solvent is MeOH or 20% MeOH/H2O. When proceeding first order graphical analysis of these two compounds, we find that k of TLM is almost ten folds to B. After that, we use TLM, which possess more sensitive property to UV light. With different concentrations, alcohol solvents, and concentrations of 20% MeOH/H2O, to look forward to find out the exact photokinetic model of TLM. In our experimental model, the kinetic of TLM of high concentration is zero order. As for the results of using three alcoholic solvents, they showed an inverse proportional relationship between kinetics and dielectric constant of TLM. Hence we supposed that photokinetics of TLM might go through free radical reaction instead of ionic reaction.
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Mohammadi, A., I. Haririan, I. Rezanour, L. Ghiasi, and Roderick Walker. "A stability-indicating high performance liquid chromatographic assay for the determination of orlistat in capsules." 2006. http://hdl.handle.net/10962/d1006480.
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A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 µm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02–0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.
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Smith, E. W., J. M. Haigh, and I. Kanfer. "A stability-indicating hplc assay with on-line clean-up for betamethasone 17-valerate in topical dosage forms." 1985. http://eprints.ru.ac.za/395/1/haigh_HPLC_assay.pdf.
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A stability-indicating high-performance liquid chromatographic method with on-line clean-up has been developed for the analysis of betamethasone 17-valerate in topical dosage forms. A short pre-column containing 10 μm octadecylsilane mounted into the sample loop position of an injection valve was used as the primary clean-up step. The utilization of a diode-array UV detector allowed the quantitative analysis of betamethasone 17-valerate together with its degradation product, betamethasone 21-valerate, as well as the qualitative analysis of these compounds, relevant internal standards and the preservatives chlorocresol and methyl hydroxybenzoate contained in the cream and lotion formulations, respectively. Typically, cream and lotion dosage forms were dissolved in acetonitrile and ointments in tetrahydrofuran, internal standards added and aliquots injected onto the analytical system. Dosage form excipients were retained on the loop column and back-flushed to waste with the aid of a second solvent pump while components of interest were allowed to transfer to the analytical column for quantitative analysis. The method is accurate, precise and stability indicating and permits the rapid on-line analysis of betamethasone 17-valerate from complex topical formulation matrices without prior extractions.
Books on the topic "Stability indicating assay method"
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Rp-Hplc Stability Indicating Assay and Simultaneous Estimation Method for the Combination of Glecapravir and Pibrentasvir in Tablet Dosage Form. Independently Published, 2020.
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D. China Babu, Dr, G. Sai Sri Harsha, G. Venkateswarlu, M. Alagusundaram, Shailendra Singh Narwariya, and SK Aleesha. "STABILITY INDICATING BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF APALUTAMIDE - APALUTAMIDE D3 BY USING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY IN HUMAN PLASMA." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 4. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bipn4p1ch3.
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A simple, convenient, specific,precise and highly conventional stability indicating ultra performance liquid chromatographic diode array method was developed for the quantification of Apalutamide in human plasma. The phenomenex Luna (100x4.6x5µ) column was used for apalutamide separation and mobile phase was composed with 5 mM ammonium fumarate and acetonitrile in the ratio of 15:85 v/v and buffer pH 3.5 was adjusted with glacial acetic acid and detected at 345 nm. The Apalutamide D3 used as internal standard and K2 EDTA used as coagulant.The liquid liquid extraction process used for extraction of drug from human plasma with tert butyl methyl ether. The retention times of Apalutamide and Apalutamide D3 (ISTD) was 1.48 min & 1.97 min respectively. The assay of the method was validated in human plasma in the concentration range from 307.26-200013.87 pg/ml with the accuracy and precision ranging from 3.86 to 4.87. Recovery studies were found to be 103.79%, 90.93% & 96.83% for HQC, MQC and LQC respectively. The stability of the drug was evaluated in human plasma with different conditions of auto-sampler, freeze-thaw, bench top, short term and long term stability studies were performed. The method was proved as highly sensitive and selective for the quantification of Apalutamide and determined at picogram level. There was no matrix effect observed and proved as a stability indicating method.
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Godela, Ramreddy, Yagnambhatla Rajendra, Kranthi Kumar Pola, Dr Beda Durgaprasad, and Rani Dumpala. "IMPLEMENTATION OF GREEN SOLVENT SYSTEM FOR THE ANALYSIS OF ADAPALENE IN BULK AND TOPICAL GEL FORMULATION BY RP-HPLC." In Futuristic Trends in Pharmacy & Nursing Volume 2 Book 25. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2023. http://dx.doi.org/10.58532/v2bs25p2ch3.
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A simple and rapid stabilityindicating, RP-HPLC method was ascertained to determine adapalene in bulk and gel formulation. Separation was achieved on enable C18 column (150 x 4.6mm; 5μm) under the isocratic mode of elution by using mobile system mixture of green solvents tetrahydrofuran and methanol (30:70 V/V). The flow rate was maintained at 1.0 ml/min with runtime 10min. UV detection was done at 360 nm. The method was found to be linear for series concentration ranges from 20-100µg/ml. The limit of detection and quantification were found to be 3.27and 0.025µg/ml. Results of precision and accuracy obtained were within the limits. The suggested approach was effectively employed for the determination of adapalene in a labelled formulation (gel), with a % assay of 99%. The suggested method's stability-indicating capacity is shown by evaluating forced degradation samples in which the peak purity of adapalene is determined as well as the resolution of degradant from the analyte peak. The collected findings demonstrate that the provided approach is a stability indicating method. The stated HPLC method has been verified in terms of specificity, precision, sensitivity, accuracy, linearity, and robustness according to ICH
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Sakinala, Padmavathi, Harini Vahika, Ramu Bhadrama raju, Yeellanki Krishnaveni, K. Santhosh, and Sandeep Attinti. "RP-HPLC Method Development and Validation of Stability Indicating Assay for Simultaneous Determination of Pantoprazole, Diclofenac, Chlorzoxazone in Pharmaceutical Dosage Form." In Pharmaceutical Science: New Insights and Developments Vol. 1. BP International, 2024. https://doi.org/10.9734/bpi/psnid/v1/3081.
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Mathew, Ceema. "Stability Testing and Analysis." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/jzmjyx83.
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Stability testing determines how drug quality changes over time under various environmental conditions. ICH guidelines define accelerated, intermediate, and long-term testing protocols across different climatic zones and container closure systems. Forced degradation studies employ acid/base hydrolysis, oxidation, photolysis, and thermal stress to identify degradation pathways, establish degradation product profiles, and develop stability-indicating methods. These studies generate samples containing degradation products at detectable levels, creating worst-case scenarios for method development. Stability-indicating methods separate and quantify degradation products with demonstrated specificity under stress conditions. Data interpretation applies trend analysis, shelf-life determination, and statistical approaches including regression analysis and tolerance intervals. Stability protocols integrate with product development from early formulation screening through post-approval changes, creating specifications for storage conditions, retest periods, and shelf-life claims.
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Nagarajan, Balaji, and Gunasekar Manoharan. "Determination of Related Substances in Lansoprazole Intermediate by Using Stability-indicating HPLC Method." In Advanced Concepts in Pharmaceutical Research Vol. 6. B P International, 2024. http://dx.doi.org/10.9734/bpi/acpr/v6/7657c.
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Gawai, Sandhya R., Kiran Gadge, and Sandeep Sonwane. "Study on Development and Validation of Stability Indicating RP-HPLC Method for Guaifenesin." In Technological Innovation in Pharmaceutical Research Vol. 11. Book Publisher International (a part of SCIENCEDOMAIN International), 2021. http://dx.doi.org/10.9734/bpi/tipr/v11/3644f.
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Bhangale, Charushila, Sachin Somwanshi, Kiran Kotade, and Mayur Gaikar. "QbD Approach to Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Green Assessment Method." In Pharmaceutical Science: New Insights and Developments Vol. 2. BP International, 2025. https://doi.org/10.9734/bpi/psnid/v2/4074.
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Mumtha, L., S. N. Meyyanathan, and S. T. Narenderan. "Determination of Dienogest in Pure Form and Pharmaceutical Preparation by Stability-indicating Spectrophotometric Method." In Challenges and Advances in Chemical Science Vol. 9. Book Publisher International (a part of SCIENCEDOMAIN International), 2022. http://dx.doi.org/10.9734/bpi/cacs/v9/15492d.
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Sankar, Panchumarthy Ravi, Kamma Harsha Sri, Ch V. Prasada Rao, and Gangisetty Jhansi. "Stability Indicating RP-HPLC Method for the Estimation of Olutasidenib in Bulk Pharmaceutical Formulations." In Pharmaceutical Science: New Insights and Developments Vol. 2. BP International, 2025. https://doi.org/10.9734/bpi/psnid/v2/4023.
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Zhang, Yuhang. "Research on Power System Fault Diagnosis Methods Based on Intelligent Algorithms." In Frontiers in Artificial Intelligence and Applications. IOS Press, 2025. https://doi.org/10.3233/faia250410.
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In order to solve the problem of poor stability of the current power system, the research of power system fault diagnosis method based on intelligent algorithms is proposed. This paper introduces in detail the application of intelligent sensor networks in power system fault processing, focusing on the overall architecture of the system, the design of fault localization system, and the application of recovery methods. The experimental results show that the OLTA algorithm shows good performance in different scenarios. The fault localization time is generally short, indicating that the algorithm can respond to the fault events quickly. The recovery time is also within a reasonable range, showing the algorithm’s ability to quickly restore the normal operation of the system after dealing with faults. The system stability index is close to 1, indicating that the system maintains high stability during the load transfer process. Conclusion: The data on economic costs show the acceptability of the algorithm in terms of economic efficiency. Overall, these results demonstrate the effectiveness and practicality of the OLTA algorithm in power system fault handling, and prove its potential in improving power system stability and economic efficiency.
Conference papers on the topic "Stability indicating assay method"
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Čakanišin, Adrián, and Mária Halenárová. "Monte Carlo as a Method for Examining of Business Changes in Tourism in Slovakia." In 25th International Joint Conference Central and Eastern Europe in the Changing Business Environment. Vydavateľstvo EKONÓM, 2025. https://doi.org/10.53465/ceecbe.2025.9788022552257.50-63.
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The business environment in tourism encompasses a set of factors influencing the establishment, development, and sustainability of businesses in this sector, including economic, legislative, and market conditions. The dynamics of this environment are crucial for the economic stability of the sector. The main objective of this paper is to model the development of business establishments and closures in the tourism sector based on historical data and the influence of selected factors. The data used for this study were obtained from the Statistical Office of the Slovak Republic upon request. To achieve this objective, correlation and regression analysis were employed to examine relationships between economic variables, while a Monte Carlo simulation was used to predict future business activity trends. The results indicated that there are only moderately statistically significant relationships between economic factors and business establishment or closure. Domestic tourists' expenditures showed a weak positive correlation with business formation, whereas expenditures on inbound tourism had the opposite effect. The Monte Carlo simulation suggested that, assuming historical trends continue, the number of newly established businesses will stabilize at around 7,500 per year, while the number of closed businesses will be approximately 6,000 per year. Extreme scenarios demonstrated that economic fluctuations could lead to significant deviations, with the pessimistic scenario predicting a higher number of business closures and the optimistic scenario indicating a more favorable sectoral development.
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Okocha, Cyril, Tao Chen, Alex Thornton, and Qiwei Wang. "Development of a Squeezable Iron Sulfide Scale Inhibitor for Ultra-Tight Sandstone." In CONFERENCE 2022. AMPP, 2022. https://doi.org/10.5006/c2022-17896.
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Abstract Iron sulfide scaling can manifest both downhole and topside in sour production scenarios. Topsides development can be mitigated via continuous strategic application of an appropriate sulfide scale inhibitor package, however downhole sulfide scaling presents a more complex challenge. Continuous downhole application of sulfide scale inhibitors via capillary string and valve, or routed to valve via existing gas lift architecture are two common delivery options available to the operator, but are unfortunately both limited to providing scale control at injection valve depth and up-string. More recent options for sulfide scale control from reservoir to wellhead include chemical impregnated proppant for prop-frack and gravel packed wells, however these approaches present a partial solution, and require topping-up of inhibitor chemical active once the emplaced inhibitor becomes exhausted. Scale squeezing is the industry recognized chemical technology for providing proactive scale control from reservoir to wellhead, however for sulfide scale control scenarios this technology option is currently poorly served as the industry lacks effective and robust sulfide squeeze scale inhibitors. A new squeezable polymeric iron sulfide scale inhibitor has been developed and engineered with optimum desirable scale squeeze characteristics, and then further tailored for application in high temperature, high salinity sour gas ultra-tight sandstone/chalk formations. The new molecule used the basic structure of an existing novel class of sulfide scale inhibitor, however the sequence and nature of functional groups across the polymer backbone were extensively modified and optimized to improve (i) polymer retention and release character for extended squeeze lifetime, (ii) thermal stability, (iii) high calcium brine compatibility and (iv) low formation damage potential. Prior to upscaling for bulk manufacture and subsequent field application, the new polymeric iron sulfide scale inhibitor (FeS-SQSI) was formation damage coreflood tested using target well field conditions and ultra-tight sandstone field core. The results of this remarkable coreflood investigation are presented below, where core permeabilities of sub-0.001 mD were the norm. The flood was performed without interruption or issue, and achieved consistent and continuous formation damage data assessment throughout the 5-week post squeeze shut-in flowback period at very low flowrates. Sulfide scale inhibitor residuals assay observed consistently elevated concentrations of scale inhibitor across the coreflood flowback ‘plateau phase’ and indicated that the squeeze treatment could generate significant squeeze lifetime, and this is further born out by mass balance performed after deliberate premature termination of the coreflood indicating that in excess of 90% of the injected scale inhibitor remained within the core. Monitoring showed sandstone core permeability recovering rapidly following start of backflow, with no evidence of any significant formation damage. Post-flood data indicated no loss of core plug integrity, and mineralogical assay confirmed unchanged material composition. The formation damage sandstone coreflood results clearly demonstrated the suitability and robustness of this new iron sulfide scale inhibitor for squeeze application under extremely challenging squeeze application conditions.
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Imano, Shinya, Jun Sato, Koji Kajikawa, and Tatsuya Takahashi. "Mechanical Properties and Manufacturability of Ni-Fe Base Superalloy (FENIX-700) for A-USC Steam Turbine Rotor Large Forgings." In AM-EPRI 2007, edited by R. Viswanathan, D. Gandy, and K. Coleman. ASM International, 2007. https://doi.org/10.31399/asm.cp.am-epri-2007p0424.
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Abstract To develop 10-ton class forgings with adequate long-term strength and without segregation defects for A-USC steam turbine rotors, researchers modified the chemical composition of Alloy 706 to improve its microstructure stability and segregation properties. The modified Alloy, named FENIX-700, is a γ' phase strengthened alloy without a γ" phase, and its microstructure stability is superior to Alloy 706 at 700°C, as demonstrated by short-term aging tests and phase stability calculations using the CALPHAD method. A trial disk 1-ton class forging of FENIX-700 was manufactured from a double-melted ingot, with tensile and creep strength of the forging equivalent to that of 10-kg class forgings, indicating a successful trial. Long-duration creep tests were performed using 10-kg class forgings, revealing an approximate 105-hour creep strength at 700°C higher than 100 MPa. Manufacturability tests showed that FENIX-700 performs better than Alloy 706, as evidenced by segregation tests using a horizontal directional solidification furnace and hot workability tests. Microstructure observation and tensile tests on 10,000-hour aged specimens (at temperatures of 650, 700, and 750°C) revealed degradation of tensile strength and yield stress due to coarsening of the γ' phase, but also showed enhanced ductility through aging. The microstructure stability of FENIX-700 at 700°C was confirmed as excellent through microstructure observation of the 10,000-hour aged sample and supporting thermodynamic considerations.
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Corle, Ethan, Matt Floros, and Sven Schmitz. "CFD/CSD Aeroelastic Predictions of a Semi-Span Tiltrotor." In Vertical Flight Society 80th Annual Forum & Technology Display. The Vertical Flight Society, 2024. http://dx.doi.org/10.4050/f-0074-2018-12709.
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This work focuses on steps towards the ability to use tight coupling between computation fluid dynamics (CFD) and rotorcraft comprehensive analysis (CSD) to predict aeroelastic stability of a rotor. First, the Rotorcraft Comprehensive Analysis System (RCAS) analysis is used to carry out traditional linear stability analysis. Next, a method of using trim springs to artificially increase the stability of the wing so that a periodic solution during the RCAS trim procedure is presented. RCAS is then used to complete time-integrated transient analysis using a lifting-line aerodynamic model following a system perturbation through a vertical force located at the wing tip. CFD/CSD coupling is used for the first time to simulate a fully-elastic semi-span tiltrotor model. Loose coupling is used to achieve a trimmed solution for a sweep of airspeeds. Tight coupling is used to observe the transient behavior of the system following a perturbation. Low-speed results are promising and clearly demonstrate differences between the higher-fidelity method and comprehensive analysis indicating Helios is capturing previously missed aerodynamic effects. At higher speeds, the perturbation used here is found to be inadequate for activating the wing beam bending mode. Finally, the tight coupling procedure predicts an unstable rotor mode that is not predicted by comprehensive analysis. The primary objective of this work is to demonstrate new capabilities introduced to the CREATE-AV software Helios and RCAS which allow for a first fully-elastic semi-span simulation of a tiltrotor using high-fidelity analysis through both loose and tight coupling methodologies.
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PASCHALIS, GIULIA, Paulo Cesar Rosa, and PAULA ROBERTA CAUMO DE CAMARGO. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR DRUGS AND CHARACTERIZATION OF DEGRADATION PRODUTS." In XXIV Congresso de Iniciação Científica da UNICAMP - 2016. Galoa, 2016. http://dx.doi.org/10.19146/pibic-2016-51757.
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Seijas, Julio A., Manik Ghosh, Debanchal Dutta, and Soumyajit Das. "VALIDATED STABILITY- INDICATING HPTLC METHOD FOR NINTEDANIB & CHARACTERIZATION OF DEGRADANTS BY LC-MSn." In The 23rd International Electronic Conference on Synthetic Organic Chemistry. MDPI, 2019. http://dx.doi.org/10.3390/ecsoc-23-06502.
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Merienne, C., D. Semely, E. Wolff, et al. "PP-046 A stability indicating hplc-uv method for quantification of simvastatin and detection of its impurities in oral capsules." In 22nd EAHP Congress 22–24 March 2017 Cannes, France. British Medical Journal Publishing Group, 2017. http://dx.doi.org/10.1136/ejhpharm-2017-000640.493.
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Patil, Sushil, Sunil Amurutkar, and C. Upasani. "A stability indicating RP-HPLC method development and validation for the estimation of combined tablet formulation of Amlodipine & Candesartan." In 4th International Electronic Conference on Medicinal Chemistry. MDPI, 2018. http://dx.doi.org/10.3390/ecmc-4-05585.
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Ferres, H., M. J. Hibbs, and R. A. G. Smith. "THE DEACYLATION OF P-ANISOYL PLASMINOGEN-STREPTOKINASE ACTIVATOR COMPLEX (APSAC, EMINASE™)." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1642994.
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The deacylation of the thrombolytic acyl-enzyme APSAC (BRL 26921) has been studied in various media using a radiochemical method. In a buffer containing glycerol, the half-life for deacylation at pH 7.4, 37°C vi/as c. 20-50 min. depending on the concentration of APSAC. The concentration-dependence u/as found to be linked to the availability of free enzyme active centres during the deacylation process and could be normalised to about 50 min. by addition of inhibitors of plasmin or streptokinase, plasmin. In glycerol-free buffer, the deacylation half-life was 147 ± 5 min., indicating that glycerol, which is required to stabilise SK.Pm in activity-based assays caused artefactual acceleration of deacylation. In human plasma, the deacylation half-life was 104 ± 6 min. and was not concentration-dependent. In clotted human plasma, under conditions where APSAC was fibrin-bound, the deacylation half-life was 128 ± 10 min. which suggested that the deacylation process was not significantly influenced by binding of molecule to fibrin. The deacylation rate of APSAC in human plasma was similar to the plasma clearance rate at therapeutic doses in man (Been, M. et al., Int. J. Cardiol. 11 (1980) 53-61)
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Sahoo, Debasish, Virendra Vaishnav, Tanushree Chatterjee, and Navita Gupta. "HERBAL DIETARY SUPPLEMENT – A MODERN APPROACH IN COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) IN HEALTH CARE SCIENCE." In International Conference on Public Health and Medical Sciences. Goodwood Conferences, 2022. http://dx.doi.org/10.35912/icophmeds.v1i1.24.
Full textAbstract:
Preliminary pharmacological study of herbal based dietary supplement formulation based on extracts or whole plants derived from fruits, root, berries, macrofungus and leaves as a promising, safe and effective alternative to synthetic and pharmaceutical dietary supplements, in-vitro studies such as antibacterial, anti-oxidant and anti-inflammatory activity for extract of dietary supplements. Nutritional assessment of nutritional attributes as suggested by AOAC method, Phytochemical analysis by standard chemical procedures, Quantitative estimate Alkaloid, Flavonoid, Phenolic, Tannin. In-vitro studies of anti-microbial (well diffusion), anti-oxidant assay (DPPH assay), anti-inflammatory assay (albumin denaturation assay). FTIR analysis for detection of different functional group. The finding suggest that the plant extract have a better nutritional aspect. The extracts for the food supplement showed positive results for anti-microbial, anti-oxidant and anti-inflammatory activity. More studies has to be concluded in respect to in-vivo tests that will conclude other pharmacological aspect of the food supplements. Reduced concentration of heavy metals and other contaminants will increase the therapeutical potency of the supplement. Stability, hold time study, dose and dosage form must be concluded in respect to achieve maximum efficacy. The herbal dietary supplement tend to better option against chemical based multi-vitamins and dietary supplements. These will enact the general well-being along with other pharmacological activities due to presence of phytochemicals present in the supplement.
Reports on the topic "Stability indicating assay method"
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Scobie, Linda, Liam O'Connor, Martin D’Agostino, et al. Thermal Inactivation Model for Hepatitis E Virus (HEV). Food Standards Agency, 2022. http://dx.doi.org/10.46756/sci.fsa.sdt366.
Full textAbstract:
Hepatitis E is an emerging issue, with the number of confirmed cases in the UK increasing in 2009-2015, and decreasing slightly in 2016 and 2017. There is some epidemiological evidence of an association of this virus with undercooked pork and pork products. Currently, there is no standardized method for evaluating thermal stability of HEV and also a lack of a suitable assay that can distinguish between intact HEV that can cause an infection and damaged virus which is not capable of causing an infection. This has raised concerns as it is extremely difficult to extrapolate the risk from pork products in relation to cooking practices. We are seeking to address this knowledge gap, which will not only inform our risk assessment, but will also provide an indication if cooking is sufficient to inactivate the virus in foods
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Chutimaworapan, Suchada, Chaiyo Chaichantippayuth, and Areerat Laopaksa. Formulation of pharmaceutical products of Garcinia mangostana Linn. extracts. Chulalongkorn University, 2006. https://doi.org/10.58837/chula.res.2006.32.
Full textAbstract:
Part I: The purpose of the investigation was to develop the extraction process that was simple, practical and giving high yield. The maceration of dried powder of Garcinia mangostana fruit husk with ethyl acetate gave yellow crystalline powder of mangostin. The yield was calculated as 7.47%. The identification of the Garcinia mangostanahusk extract was carried out by thin-layer chromatography (TLC) and differential scanning calorimetry. The TLC of mangostin was done by using the alumina sheet and ethyl acetate: hexane (3:1) as mobile phase. The Rf value as compared with standard mangostin was 0.60. The DSC thermogram showed the board melting range of the crude extract at 165.04-166.80 °C. The quantitative analyses of mangostin were developed using the high performance liquid chromatography (HPLC) and ultraviolet (UV) spectrophotometry. The HPLC system using methanol: water (87:13) as mobile phase, clotrimazole as internal standard and using UV detector at 243 nm. The UV spectrophotometric method was carried out using the UV spectrophotometer at 243 nm. The validation of both systems gave high specificity, linearity, accuracy and precision. The solubility study of mangostin showed the low water insolubility. The water solubility was improving with increasing ethanol content. The in vitro microbiological activity of mangostin to Staphylococcus aureus ATCC 25923 and Streptococcus mutans ATCC KPSK2 was studied. The minimum inhibitory concentrations of the extract were 3 µg/ml and 1.5 µg/ml, respectively. The minimum bactericidal concentrations of the extract was 4 µg/ml and 3 µg/ml, respectively.Part II: The purpose of this study was to develop fast dissolving oral strips containing Garcinia mangostana husk extract. The films consisted of low viscosity hydrophilic polymers such as hydroxypropyl methylcellulose and hydroxypropylcellulose, acesulfame potassium as sweetener, and menthol and eucalyptus oil as flavoring agents. The physical and mechanical properties and dissolution time of film bases were compared with commercial product strips A. From the dissolution time data, it was found that the film prepared from mixed polymer between HPMC 3 cps and HPC LV at ratios 2:1, 3:1, 4:1 and 5:1 were not significantly different from commercial product strips A (p>0.05). The films containing extract were light yellow and had porous surface based on observation from scanning electron microscopy. The dissolution profiles of all formulations showed the rapid release more than 80 percent of mangostin from films within 3-7 minutes and the fastest release was from formulation of HPMC 3 cps and HPC LV at ratio 5:1. Differential scanning calorimetry results exhibited that the Garcinia mangostana extract and additives were not in crystalline form in the films. The fast dissolving oral strips containing Garcinia mangostana husk extract showed in vitro antimicrobial activity against oro-dental bacteria, namely, Staphylococcus aureus aTCC 25923 and Streptococcus mutans ATCC KPSK2. Unter strese conditions at 40 degree Celcius and 75 percent relative humidity, the strips showed a good stability.The purpose of the study was to develop monoglyceride-based drug delivery systems containing Garcinia Mangostana extract. The system is based on the ability of mixtures of monoglyceride (dlyceryl monooleate) and triglycerides to form liquid crystals upon contact with water. The drug delivery systems can be administered by syringe and transformed into high-viscous liquid crystalline phases at the injection site. Ternary phase diagrams were constructed from various triglycerides: sesame oil, soybean oil and olive oil. In this study, monoglyceride-based drug delivery systems were prepared in the ratio of triglycerides: monoglyceride: water as 8: 62: 30 and 12: 58: 30. These systems could sustain release of Garcinia Mangostana husk extract over a period of 48 hr and followed squared root of time kinetics during the initial 24 hr of the release phase, indicating that the rate of release was diffusion-controlled. The system containing sesame oil showed the highest drug release. The increasing triglyceride content did not affect the release profiles. Differential scanning calorimetry results demonstrated that Garcinia Mangostana husk extract could be incorporated into drug delivery systems without causing phase transition. In the in vitro test, monoglyceride-based drug delivery systems containing Garcinia mangostana husk extract did not show the antimicrobial activity probably due to the high lipophilicity of the extract therefore it did not diffuse into the medium. Additionally, the drug delivery systems containing Garcinia mangostana husk extract showed good stability under the stress condition.