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Journal articles on the topic 'Drug forced degradation'

Author: Grafiati
Published: 4 June 2021
Last updated: 15 February 2022

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1

Yulianita, Rini, Iyan Sopyan, and Muchtaridi Muchtaridi. "FORCED DEGRADATION STUDY OF STATINS: A REVIEW." International Journal of Applied Pharmaceutics 10, no. 6 (2018): 38. http://dx.doi.org/10.22159/ijap.2018v10i6.29086.

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Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability st
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2

Bhaskar, Rajveer, Monika Ola, Vinit Agnihotri, Arjun Chavan, and Harpalsing Girase. "Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s." Journal of Drug Delivery and Therapeutics 10, no. 2-s (2020): 149–55. http://dx.doi.org/10.22270/jddt.v10i2-s.4040.

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The stability of a new drug substances and new drug products is a vital parameter which may affect purity, safety & potency. Changes in drug stability can threat patient safety by formation of toxic degradation products or deliver to lower dose than expected. Therefore it is to know the purity profile & behaviour of a drug substances under the various environmental condition. Forced Degradation studies show the chemical behavior of the molecule which in turn helps in the development of new formulation & package . Degradation study is required to the design of a regulatory compliant
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3

Mladenovic, Aleksandar, Milka Jadranin, Aleksandar Pavlovic, et al. "Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products." Chemical Industry and Chemical Engineering Quarterly 21, no. 3 (2015): 447–55. http://dx.doi.org/10.2298/ciceq141023047m.

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This study describes the investigation of degradation products of donepezil (DP) using stability indicating RP-HPLC method for determination of donepezil, which is a centrally acting reversible acetylcholinesterase inhibitor. In order to investigate the stability of drug and formed degradation products, a forced degradation study of drug sample and finished product under different forced degradation conditions has been conducted. Donepezil hydrochloride and donepezil tablets were subjected to stress degradation conditions recommended by International Conference on Harmonization (ICH). Donepezi
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4

Mehta, Tushar N., Atul K. Patel, Gopal M. Kulkarni, and Gunta Suubbaiah. "Determination of Rosuvastatin in the Presence of Its Degradation Products by a Stability-Indicating LC Method." Journal of AOAC INTERNATIONAL 88, no. 4 (2005): 1142–47. http://dx.doi.org/10.1093/jaoac/88.4.1142.

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Abstract A forced degradation study was successfully applied for the development of a stability-indicating assay method for determination of rosuvastatin Ca in the presence of its degradation products. The method was developed and optimized by analyzing the forcefully degraded samples. Degradation of the drug was done at various pH values. Moreover, the drug was degraded under oxidative, photolytic, and thermal stress conditions. Mass balance between assay values of degraded samples and generated impurities was found to be satisfactory. The proposed method was able to resolve all of the possib
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5

Jaya P. Ambhore, Vaibhav S. Adhao, Rameshwar S. Cheke, Rameshwar S. Cheke, Ritesh R. Popat, and Shital J. Gandhi. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. http://dx.doi.org/10.30574/gscbps.2021.16.1.0172.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summa
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6

CARLSON, E., W. CHANDLER, I. GALDO, T. KUDLA, and C. TA. "Automated Integrated Forced Degradation and Drug-Excipient Compatibility Studies." Journal of the Association for Laboratory Automation 10, no. 6 (2005): 374–80. http://dx.doi.org/10.1016/j.jala.2005.09.005.

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7

Bansal, Gulshan, Manjeet Singh, Kaur Chand Jindal, and Saranjit Singh. "Ultraviolet-Photodiode Array and High-Performance Liquid Chromatographic/Mass Spectrometric Studies on Forced Degradation Behavior of Glibenclamide and Development of a Validated Stability-Indicating Method." Journal of AOAC INTERNATIONAL 91, no. 4 (2008): 709–19. http://dx.doi.org/10.1093/jaoac/91.4.709.

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Abstract A forced degradation study on glibenclamide was performed under conditions of hydrolysis, oxidation, dry heat, and photolysis and a high-performance column liquid chromatographic-ultraviolet (HPLC-UV) method was developed to study degradation behavior of the drug under the forced conditions. The degradation products formed under different forced conditions were characterized through isolation and subsequent infrared/nuclear magnetic resonance/mass spectral analyses, or through HPLC/mass spectrometric (HPLC/MS) studies. The drug degraded in 0.1 M HCl and water at 85C toamajor degradati
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8

Roberto de Alvarenga Junior, Benedito, and Renato Lajarim Carneiro. "Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs." Molecules 24, no. 20 (2019): 3804. http://dx.doi.org/10.3390/molecules24203804.

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Chemometrics is the chemistry field responsible for planning and extracting the maximum of information of experiments from chemical data using mathematical tools (linear algebra, statistics, and so on). Active pharmaceutical ingredients (APIs) can form impurities when exposed to excipients or environmental variables such as light, high temperatures, acidic or basic conditions, humidity, and oxidative environment. By considering that these impurities can affect the safety and efficacy of the drug product, it is necessary to know how these impurities are yielded and to establish the pathway of t
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9

Michail, Karim, Hoda M. Daabees, Youssef Beltagy, Magdi Abdel-Khalek, and Mona M. Khamis. "Stress Degradation Assessment of Lamotrigine Using a Validated Stability-Indicating HPTLC Method." Journal of Chemistry 2013 (2013): 1–6. http://dx.doi.org/10.1155/2013/608196.

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In this work, a sensitive and stability-indicating HPTLC method for the determination of lamotrigine is presented. According to the International Conference on Harmonization guidelines Q1A, lamotrigine was exposed to a variety of stress conditions; these include heating in acidic, basic and neutral media. Its stability towards oxidative stress, humidity, high temperature and direct sunlight was also examined. Separation of the drug from its forced degradation impurities was achieved using TLC silica gel plates and a mobile phase composed of ethyl acetate: methanol: ammonia. The linear regressi
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10

Sharma, Ritesh, and Shyam Pancholi. "RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions." Acta Pharmaceutica 60, no. 1 (2010): 13–24. http://dx.doi.org/10.2478/v10007-010-0010-2.

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RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditionsA simple, sensitive and precise RP-HPLC-DAD method was developed and validated for the determination of olmesartan medoxomil (AT-II receptor blocker) in the presence of its degradation products. Olmesartan medoxomil and all the degradation products were resolved on a C18column with the mobile phase composed of methanol, acetonitrile and water (60:15:25,V/V/V, pH 3.5 by orthophosphoric acid) at 260 nm using a photodiode array detector. The method was linear over the concentration range o
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11

Rashmitha, N., T. Joseph Sunder Raj, Ch Srinivas, et al. "A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium." E-Journal of Chemistry 7, no. 2 (2010): 555–63. http://dx.doi.org/10.1155/2010/156593.

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The present paper describes the development of a reverse phase chromatographic (RPLC) method for montelukast sodium in the presence of its impurities and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of montelukast sodium was observed under acid and oxidative environment. The drug was found to be stable in other stress conditions studied. Successful separation of the drug from the process impurities and degradation products formed under stress co
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12

Pires, Sumaia Araújo, Letícia Martins Mota, Jerusa Simone Garcia, et al. "LC-MS characterization of valsartan degradation products and comparison with LC-PDA." Brazilian Journal of Pharmaceutical Sciences 51, no. 4 (2015): 839–45. http://dx.doi.org/10.1590/s1984-82502015000400010.

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abstract Valsartan was submitted to forced degradation under acid hydrolysis condition as prescribed by the ICH. Degraded sample aliquots were separated via HPLC using a Hypersil ODS (C18) column (250 x 4.6 mm i.d., 5 µm). Either photodiode array (PDA) detection or mass spectrometry (MS) full scan monitoring of HPLC runs were used. HPLC-PDA failed to indicate Valsartan degradation under forced acid degradation, showing an insignificant peak area variation and that Valsartan apparently remained pure. HPLC-MS using electrospray ionization (ESI) and total ionic current (TIC) monitoring did not re
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13

Gawande, Vandana, and Varsha Jadhav. "Validated stability indicating assay method for tenofovir implementing design of experiment approach for forced degradation." International Journal of Bio-Pharma Research 8, no. 1 (2019): 2468–75. http://dx.doi.org/10.21746/ijbpr.2019.8.1.1.

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Tenofovir, an antiretroviral drug known as nucleoside analogue reverse transcriptase inhibitor, was evaluated for its degradation behavior. The study involved optimization of forced degradation study using the design of experiment (DoE) approach and validation of developed stability indicating assay method (SIAM) for tenofovir. Chromatographic separation was achieved on Kromasil C18 column using mixture of methanol and ammonium acetate buffer pH 8.5 as mobile phase in isocratic elution mode. Detection was done using PDA detector. Tenofovir showed degradation at alkali, acid hydrolysis and oxid
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14

Babu, M. Ajay, G. V. Krishna Mohan, N. Naresh, Ch Krishnam Raju, and Sharad D. Mankumare. "Identification and Characterization of Forced Degradation Products for Dofetilide using Rapid and Sensitive UPLC-MS/MS Method and HRMS Studies." Asian Journal of Chemistry 31, no. 12 (2019): 2763–69. http://dx.doi.org/10.14233/ajchem.2019.22220.

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A simple, rapid and efficient method has been developed and validated using ultra UPLC combined with Q-ToF MS system for recognition and characterization of forced degradation products obtained from dofetilide degradation studies. The dofetilide drug is an antiarrhythmic and belongs to Class III and it was treated with various stress conditions like acidic, basic, oxidative, photolytic and thermal conditions as per ICH guidelines. The main drug shows extensive degradation towards oxidative degradation conditions and single degradation product was identified through chromatogram. The chromatogr
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15

Gumieniczek, Anna, Anna Berecka-Rycerz, Emilia Fornal, Barbara Żyżyńska-Granica, and Sebastian Granica. "Comprehensive Insight into Chemical Stability of Important Antidiabetic Drug Vildagliptin Using Chromatography (LC-UV and UHPLC-DAD-MS) and Spectroscopy (Mid-IR and NIR with PCA)." Molecules 26, no. 18 (2021): 5632. http://dx.doi.org/10.3390/molecules26185632.

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During forced degradation, the intrinsic stability of active pharmaceutical ingredients (APIs) could be determined and possible impurities that would occur during the shelf life of the drug substance or the drug product could be estimated. Vildagliptin belongs to relatively new oral antidiabetic drugs named gliptins, inhibiting dipeptidyl peptidase 4 (DPP-4) and prolonging the activities of the endogenous incretin hormones. At the same time, some gliptins were shown as prone to degradation under specific pH and temperature conditions, as well as in the presence of some reactive excipients. Thu
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16

Jain, P. S., H. N. Jivani, R. N. Khatal, and S. J. Surana. "Stability-indicating HPLC determination of ciprofibrate in bulk drug and pharmaceutical dosage form." Chemical Industry and Chemical Engineering Quarterly 18, no. 1 (2012): 95–101. http://dx.doi.org/10.2298/ciceq110824052j.

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A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of ciprofibrate in bulk drugs and in pharmaceutical dosage form in the presence of degradation products. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250?4.6 mm, 5 ?m) advance chromatography column, and methanol and water (90:10 v/v) as a mobile phase. The detection was carried out at a wavelength of 232 nm. The ciprofibrate was subjected to stress conditions of hydrolysis (a
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17

Modhave, Dattatray, Brenda Barrios, and Amrit Paudel. "PVP-H2O2 Complex as a New Stressor for the Accelerated Oxidation Study of Pharmaceutical Solids." Pharmaceutics 11, no. 9 (2019): 457. http://dx.doi.org/10.3390/pharmaceutics11090457.

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Reactive impurities, such as hydrogen peroxide in excipients, raise a great concern over the chemical stability of pharmaceutical products. Traditional screening methods of spiking impurities into solid drug-excipient mixtures oversimplify the micro-environment and the physical state of such impurities in real dosage form. This can lead to an inaccurate prediction of the long-term product stability. This study presents the feasibility of using a polyvinylpyrrolidone-hydrogen peroxide complex (PVP-H2O2) as an oxidative agent for the solid state forced degradation of a selected drug, vortioxetin
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18

Sversut, Rúbia Adrieli, James Cabral Vieira, Nájla Mohamad Kassab, Denise Brentan Silva, and Hérida Regina Nunes Salgado. "Forced degradation behavior of two-drug combinations: Isolation and characterization of major degradation products by LC-MS." Microchemical Journal 150 (November 2019): 104074. http://dx.doi.org/10.1016/j.microc.2019.104074.

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19

Patel, Sejal K., and Natvarlal J. Patel. "Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Atomoxetine Hydrochloride in Tablets." Journal of AOAC INTERNATIONAL 93, no. 4 (2010): 1207–14. http://dx.doi.org/10.1093/jaoac/93.4.1207.

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Abstract This paper describes the development of a stability-indicating RP-HPLC method for the determination of atomoxetine hydrochloride (ATX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. In stability tests, the drug was susceptible to acid, base, oxidation, and dry and wet heat degradation. It was found to be stable under the photolytic conditions tested. The drug was successfully separated from the degradation products formed u
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20

Tailor, Pratik M., and Dr Shailesh A. Shah. "Forecasting the Protocol for Microwave Radiation Availed Forced Degradation of the Drug Molecules." International Journal For Research in Applied Sciences and Biotechnology 7, no. 6 (2020): 131–33. http://dx.doi.org/10.31033/ijrasb.7.6.19.

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21

Qiu, Fenghe, Diego Cobice, Scott Pennino, Mariela Becher, and Daniel L. Norwood. "Identification of Drug Meglumine Interaction Products Using LC/MS and Forced Degradation Studies." Journal of Liquid Chromatography & Related Technologies 31, no. 15 (2008): 2331–36. http://dx.doi.org/10.1080/10826070802281802.

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22

D, Debaje Priyanka, and Chavan Harishchandra H. "Force Degradation Study of Tenofovir Disoproxil Fumarate by UV-Spectrophotometric Method." Asian Journal of Pharmaceutical Research and Development 8, no. 2 (2020): 21–25. http://dx.doi.org/10.22270/ajprd.v8i2.679.

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Tenofovir disoproxil Fumarate (TDF), acyclic phosphonate nucleotide analogue, used as antiretroviral agents in the treatment of HIV-1 infection. A stability indicating UV -spectrophotometric method is simple, an accurate and economic, precise and reproducible method has been used for the estimation of Tenofovir disoproxil Fumarate in bulk and tablets dosage form in present work. The wavelength selected for the absorption correction method was 260 nm. The linearity range of 2-10μg/ml proved that it obeyed Beer’s Law and the correlation coefficient (r2) was found to be 0.999 at 260 nm. The drug
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23

Prekodravac, Bojana, Markus Damm, and C. Oliver Kappe. "Microwave-assisted forced degradation using high-throughput microtiter platforms." Journal of Pharmaceutical and Biomedical Analysis 56, no. 5 (2011): 867–73. http://dx.doi.org/10.1016/j.jpba.2011.07.042.

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Kumaraswamy, Kasani, Hima Bindu Gandham, Rudrakshula J.D. Prasad, B. Amarender Reddy, Muralidharan Kaliyaperumal, and Chidananda Swamy Rumalla. "Isolation and Characterization of Novel Degradation Products of Valsartan by NMR and High Resolution Mass Spectroscopy: Development and Validation of Valsartan by UPLC." Asian Journal of Chemistry 32, no. 5 (2020): 1064–68. http://dx.doi.org/10.14233/ajchem.2020.22526.

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Valsartan is used to treat high blood pressure, heart failure and diabetic kidney disease. It was subjected to forced degradation under acidic, basic and peroxide mediated oxidation. The forced degradation was performed according to ICH guidelines Q1A(R2)−Stability Testing of New Drug Substances and Products. The drug was inert under peroxide mediated hydrolysis, two degradants (DP-Val-1, DP-Val-2) were formed in base hydrolysis and one degradant (DP-Val-3) was formed in acid hydrolysis. These degradants were initially identified through LC-MS and isolated by mass mediated purification system.
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25

Mohan, Arivozhi, Hitesh B. Patel, and Dhandayutham Saravanan. "Development and Validation of a Reversed-Phase Ultra-Performance Liquid Chromatographic Method for Assay of Lacidipine and Related Substances." Journal of AOAC INTERNATIONAL 94, no. 6 (2011): 1800–1806. http://dx.doi.org/10.5740/jaoacint.10-223.

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Abstract A simple isocratic, RP-ultra-performance LC method was developed and validated for the determination of lacidipine, three process impurities formed during synthesis, and three degradation products present in drug substance and the drug product. An efficient chromatographic separation was achieved on an Acquity BEH C18 column using pH 4.5 ammonium acetate–acetic acid buffer–methanol (70 + 30, v/v) mobile phase. The monitoring wavelength was 240 nm, and the flow rate 0.25 mL/min. Forced degradation studies using acid, alkali, peroxide, water, heat, and light were conducted, and all impu
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Patel, Sejal K., Natavarlal J. Patel, Arun M. Prajapati, Dipti B. Patel, and Satish A. Patel. "Stability-Indicating RP-HPLC Method Development and Validation for Duloxetine Hydrochloride in Tablets." Journal of AOAC INTERNATIONAL 93, no. 1 (2010): 123–32. http://dx.doi.org/10.1093/jaoac/93.1.123.

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Abstract This paper describes the development of a stability-indicating RP-HPLC method for duloxetine hydrochloride (DLX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. The drug was found to be stable to the dry heat condition attempted. Successful separation of the drug from the degradation products formed under stress conditions was achieved on a Phenomenex C18 column (250 4.6 mm id, 5 µm particle size) using acetoni
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27

Parenty, Alexis D. C., William G. Button, and Martin A. Ott. "An Expert System To Predict the Forced Degradation of Organic Molecules." Molecular Pharmaceutics 10, no. 8 (2013): 2962–74. http://dx.doi.org/10.1021/mp400083h.

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28

Bhardwaj, Shalini, M. K. Gupta, and V. Bhalla. "METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE." International Journal of Drug Regulatory Affairs 3, no. 4 (2018): 24–42. http://dx.doi.org/10.22270/ijdra.v3i4.174.

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A simple and rapid stability indicating, ultra performance liquid chromatographic (UPLC) method was developed and validated for the determination of Nifedipine. The quantitative determination of Nifedipine drug was performed on a Sunniest C-18-HT, 2m, (50 2.1nm) column with gradient elution. For UPLC method, UV detection was made at 335nm. During method validation, parameters such as precision, linearity, stability, robustness and specificity were evaluated, which remained within acceptable limits. Forced degradation studies of Nifedipine were studied under acidic and alkaline stress condition
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Sonawane, Sandeep S., Akshay S. Patil, Santosh S. Chhajed, Dimple S. Lalchandani, and Sanjay J. Kshirsagar. "DEVELOPMENT OF A VALIDATED STABILITY-INDICATING METHOD FOR ESTIMATION OF ETHIONAMIDE IN TABLETS BY RP-HPLC AND CHARACTERIZATION OF ITS ISOLATED ALKALI DEGRADATION PRODUCT." INDIAN DRUGS 58, no. 01 (2021): 20–27. http://dx.doi.org/10.53879/id.58.01.11233.

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A simple, accurate, reproducible and specific stability-indicating RP-HPLC method was developed for estimation of ethionamide in tablets. Ethionamide was exposed to acid, alkali and neutral hydrolysis at elevated temperatures, to thermolytic degradation, peroxide-mediated oxidation at room temperature in dark and to photolytic degradation. The drug was found stable to thermolytic and photolytic conditions and to neutral hydrolysis. However, substantial degradation was obtained in acid and alkali hydrolysis and complete degradation in peroxide-medicated oxidation. Similar degradation behavior w
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Hotha, Kishore Kumar, Satti Phani Kumar Reddy, V. Kishore Raju, and L. K. Ravindranath. "FORCED DEGRADATION STUDIES: PRACTICAL APPROACH - OVERVIEW OF REGULATORY GUIDANCE AND LITERATURE FOR THE DRUG PRODUCTS AND DRUG SUBSTANCES." International Research Journal of Pharmacy 4, no. 5 (2013): 78–85. http://dx.doi.org/10.7897/2230-8407.04517.

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Von Ahn, Alessandra, and João Henrique Z. Dos Santos. "Study of the forced degradation of isoconazole nitrate in bulk drug and cream formulations." Analytical Methods 4, no. 8 (2012): 2404. http://dx.doi.org/10.1039/c2ay05580e.

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Ravi, Thengungal Kochupappy, Muruganathan Gandhimathi, Azhewar Suganthi, and Sabitha Sarovar. "Forced-degradation study of valdecoxib as bulk drug and in tablet formulation by HPTLC." Journal of Separation Science 29, no. 11 (2006): 1647–52. http://dx.doi.org/10.1002/jssc.200600028.

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Jain, Deepti, and Pawan Kumar Basniwal. "Forced degradation and impurity profiling: Recent trends in analytical perspectives." Journal of Pharmaceutical and Biomedical Analysis 86 (December 2013): 11–35. http://dx.doi.org/10.1016/j.jpba.2013.07.013.

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Ramesh, Thippani, Pothuraju Nageswara Rao, and Ramisetti Nageswara Rao. "LC–MS/MS characterization of forced degradation products of zofenopril." Journal of Pharmaceutical and Biomedical Analysis 88 (January 2014): 609–16. http://dx.doi.org/10.1016/j.jpba.2013.10.018.

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35

Venugopal, S., U. M. Tripathi, and N. Devanna. "Validated Reverse Phase HPLC Method for the Determination of Impurities in Etoricoxib." E-Journal of Chemistry 8, s1 (2011): S119—S126. http://dx.doi.org/10.1155/2011/726385.

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This paper describes the development of reverse phase HPLC method for etoricoxib in the presence of impurities and degradation products generated from the forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of etoricoxib was observed under base and oxidation environment. The drug was found stable in other stress conditions studied. Successful separation of the drug from the process related impurities and degradation products were achieved on zorbax SB CN (250 x 4.6 mm) 5 μm particle size
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Gurrala, Sunitha, Panikumar D. Anumolu, Vasavi Panchakatla, Radhagayathri Achanta, Rajesh Chakka, and Veda Maddala. "APPLICATION OF EMISSION INTENSITY IN QUANTIFICATION AND FORCED DEGRADATION STUDIES OF MESALAMINE." INDIAN DRUGS 58, no. 03 (2021): 59–61. http://dx.doi.org/10.53879/id.58.03.11074.

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A simple and sensitive spectrofluorimetric method has been developed for the estimation of mesalamine (MES). Linearity was obeyed in the range of 0.1-2.5 µg/mL in distilled water as solvent at an emission wavelength (λem) of 501 nm after excitation (λex) at 332 nm, with a good correlation coefficient of 0.999. The limit of detection and limit of quantification for this method were 0.05 and 0.1 µg/mL, respectively. The developed method was statistically validated as per ICH guidelines. The percentage relative standard deviation values were found to be less than 2 for accuracy and precision stud
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Hasan, Md Sharif, Ruhul Kayesh, Farida Begum, and S. M. Abdur Rahman. "Transition Metal Complexes of Naproxen: Synthesis, Characterization, Forced Degradation Studies, and Analytical Method Verification." Journal of Analytical Methods in Chemistry 2016 (2016): 1–10. http://dx.doi.org/10.1155/2016/3560695.

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The aim of our current research was to synthesize some transition metal complexes of Naproxen, determine their physical properties, and examine their relative stability under various conditions. Characterizations of these complexes were done by 1H-NMR, Differential Scanning Calorimetry (DSC), FT-IR, HPLC, and scanning electron microscope (SEM). Complexes were subjected to acidic, basic, and aqueous hydrolysis as well as oxidation, reduction, and thermal degradation. Also the reversed phase high-performance liquid chromatography (RP-HPLC) method of Naproxen outlined in USP was verified for the
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Rao, R. Nageswara, B. Ramachandra, R. Mastan Vali, and S. Satyanarayana Raju. "LC–MS/MS studies of ritonavir and its forced degradation products." Journal of Pharmaceutical and Biomedical Analysis 53, no. 4 (2010): 833–42. http://dx.doi.org/10.1016/j.jpba.2010.06.004.

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Rathor, Shahbaz, and Atul Sherje. "FORCED DEGRADATION STUDIES OF TIZANIDINE HYDROCHLORIDE AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING RP-HPLC METHOD." INDIAN DRUGS 58, no. 4 (2021): 50–55. http://dx.doi.org/10.53879/id.58.04.11226.

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Simple and precise stability indicating RP-HPLC method for the quantitative determination of tizanidinehydrochloride (TZN) in pharmaceutical dosage form was developed and validated. The separation was achieved using Atlantis C18 column (250 x 4.6 mm, 5µm) at 25 °C using a mobile phase containing 20mM KH2 PO4 (pH 3.5):methanol in the ratio of 30:70 V/V at 0.8 mL/min flow rate and 315nm detection wavelength. The retention time for TZN was 3.7 min and showed linearity in the 5-40µg/mL range with R2 >0.99. The drug was subjected to acid/ base hydrolysis, oxidative and thermal degradation to est
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Brusač, Edvin, Mario-Livio Jeličić, Matija Cvetnić, Daniela Amidžić Klarić, Biljana Nigović, and Ana Mornar. "A Comprehensive Approach to Compatibility Testing Using Chromatographic, Thermal and Spectroscopic Techniques: Evaluation of Potential for a Monolayer Fixed-Dose Combination of 6-Mercaptopurine and Folic Acid." Pharmaceuticals 14, no. 3 (2021): 274. http://dx.doi.org/10.3390/ph14030274.

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In this work, a systematical compatibility investigation of 6-mercaptopurine and folic acid, two commonly used medications in the treatment of inflammatory bowel disease, for the needs of a fixed-dose combination development strategy is shown. Various techniques and approaches, such as differential scanning calorimetry, isothermal stress testing, attenuated total reflectance–Fourier-transform infrared spectroscopy, dissolution medium stability and forced degradation studies, were used to elucidate the possible interactions from different aspects. The results predominantly point to the absence
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41

Peterka, Tanja Rozman, Tina Trdan Lušin, Jure Bergles, Zoran Ham, Rok Grahek, and Uroš Urleb. "Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination." Acta Pharmaceutica 69, no. 3 (2019): 363–80. http://dx.doi.org/10.2478/acph-2019-0025.

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Abstract An ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a total run time of 14 min. The method was applied to analyses of commercial samples and was validated in terms of linearity, precision, accuracy, sensitivity and specificity. It was found to be linear, precise and accurate in the range of 0.05 to 0.6 % of the impurities level in pharmaceutical dosage forms. Stability indicatin
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Sathiyanarayanan, Singaram, Chidambaram Subramanian Venkatesan, and Senthamaraikannan Kabilan. "Synthesis and Characterization of Potential and Degraded Impurities of Regadenoson." Current Pharmaceutical Analysis 16, no. 8 (2020): 1130–39. http://dx.doi.org/10.2174/1573412915666190819095255.

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Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Methods: HPLC method was used for the analysis of related substances. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis. Results: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, fi
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Tan, Fang. "Development and Validation of Stability-Indicating HPLC Method for Roflumilast and Related Substances." Advanced Materials Research 781-784 (September 2013): 68–71. http://dx.doi.org/10.4028/www.scientific.net/amr.781-784.68.

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A reversed phase HPLC method was developed and validated for analysis of roflumilast, its related substances and degradation products, using Ecosil C18 column (250×4.6 mm, 5 μm) with a flow rate of 1.0 ml/min and detection wavelength of 215nm. The mobile phase was a mixture of acetonitrile and 0.005mol·L-1ammonium dihydrogen phosphate buffer pH 3.5 in the ratio of 48:52 (v/v). The samples were analyzed using 20 μl injection volume and the column temperature was maintained at 30°C. The limit of detection and limit of quantitation were found to be 2.6 ng/ml and 8ng/ml, respectively. The stabilit
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Jogia, Hitesh, Umesh Khandelwal, Tripti Gandhi, Sukhdev Singh, and Darshana Modi. "Development and Validation of a Stability-Indicating Assay Method for Simultaneous Determination of Perindopril and Indapamide in Combined Dosage Form by Reversed-Phase High-Performance Liquid Chromatography." Journal of AOAC INTERNATIONAL 93, no. 1 (2010): 108–15. http://dx.doi.org/10.1093/jaoac/93.1.108.

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Abstract An approach of forced degradation study was successfully applied for the development of a stability-indicating assay method for simultaneous determination of perindopril and indapamide in a formulation in the presence of its degradation products. The method showed adequate separation of perindopril and indapamide from their associated main impurities and degradation products. Separation was achieved on an XTerra<sup/> RP18, 5 µm, 150 4.6 mm id column at 55°C by using the mobile phase NaH2PO4 buffer (pH 2.0; 0.005 M)acetonitrile (75 + 25, v/v ) at a flow rate of 1 mL/min
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Kanubhai, Trivedi Rakshit, Patel Mukesh C, and Kharkar Amit R. "Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method." E-Journal of Chemistry 8, no. 1 (2011): 131–48. http://dx.doi.org/10.1155/2011/382137.

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In the present study gradient reversed-phase UPLC method was developed for simultaneous determination and separation of impurities and degradation products from drug product. The chromatographic separation was performed on acquity UPLC BEH C18 column (50 mm×2.1 mm, 1.7 µm) using gradient elution. Other UPLC parameters which were optimised are flow rate, 0.7 mL/min; detection wavelength, 220 nm; column oven temperature, 40°C and injection volume 7 µL. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was va
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Runje, Mislav, Sandra Babić, Ernest Meštrović, Irena Nekola, Željka Dujmić-Vučinić, and Nina Vojčić. "Forced degradation of nepafenac: Development and validation of stability indicating UHPLC method." Journal of Pharmaceutical and Biomedical Analysis 123 (May 2016): 42–52. http://dx.doi.org/10.1016/j.jpba.2016.02.003.

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47

Surse, Sunita N., Sushil D. Patil, Kunal R. Deshmukh, and Sanjay J. Kshirsagar. "Development and Validation of Analytical Method by RP-HPLC and Forced Degradation Studies of Tioconazole Drug." Asian Journal of Pharmaceutical Analysis 9, no. 4 (2019): 229. http://dx.doi.org/10.5958/2231-5675.2019.00039.5.

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Nikhar, Shital R., and Deepali A. Bansode. "Stability Indicating Thin-Layer Chromatographic Determination of Brivarecetam as Bulk Drug: Application to Forced Degradation Study." International Journal of PharmTech Research 11, no. 4 (2018): 351–60. http://dx.doi.org/10.20902/ijptr.2018.11406.

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49

Verma, Hitesh, Surajpal Verma, and Harmanpreet Singh. "A Stability Indicating Assay Method Development and Validation for the Frovatriptan Succinate Monohydrate by Using UV: A Spectrophotometric Technique." ISRN Spectroscopy 2013 (May 2, 2013): 1–6. http://dx.doi.org/10.1155/2013/361385.

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A new simple, reliable, inexpensive, and accurate method was developed for the quantification of Frovatriptan Succinate Monohydrate in different physiological media at 244 nm in bulk and in tablet dosage forms. The developed method is an attempt to surpass the disadvantages associated with the reported methods, namely, less sensitive and tedious in usage for routine purposes. Beer’s law was followed over the range of 1.0 µg/mL to 4.5 µg/mL. Stability indicating assay method was developed and validated as per the ICH guidelines using various parameters, for example, accuracy, precision, limit o
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Chaudhari, Yogesh Jagdish, Rama Sadashiv Lokhande, and Ravi Ramrathi Yadav. "Stability Indicating Method Development, Validation and Forced Degradation Study for Vilazodone Hydrochloride API." Oriental Journal Of Chemistry 37, no. 1 (2021): 204–12. http://dx.doi.org/10.13005/ojc/370128.

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The current study describes the short, stability indicative HPLC method development and successive validation of Assay and Related Substances methods for Vilazodone Hydrochloride API. This study also covers Vilazodone process impurities viz. Impurity A and Impurity B. The chromatographic conditions for Related Substances and Assay are similar except sample concentration. The proposed method utilizes C18 column (15 cm X 4.6 mm, 5 µ, make ZORBAX SB) and mobile phase having Methanol and 0.05 M KH2PO4 (55: 45 v/v). The separation between all three analytes was achieved in less than five minutes. T
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