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Journal articles on the topic 'The developed method is stability indicating'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Upadhyay, Priya Shitalaprasad* Dr Vinay C. Darji Bhumi Patel Jaymin Patel. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR ESTIMATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 3209–19. https://doi.org/10.5281/zenodo.1240480.

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A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for Teriflunomide In its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Teriflunomide in its Pharmaceutical Dosage Form has been developed. The separation was achieved by Cosmosil (250mm x 4.6 mm) column and Buffer (pH 4.0): Methanol (40:60) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 248 nm. Retention time of Teriflunomide was found to be 3.300 min. The method has been validated for linearity, a

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2

Alam, Prawez, Faiyaz Shakeel, Mohammed H. Alqarni, et al. "Determination of Cordycepin Using a Stability-Indicating Greener HPTLC Method." Separations 10, no. 1 (2023): 38. http://dx.doi.org/10.3390/separations10010038.

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A wide range of analytical techniques have been reported to determine cordycepin (CDN) in various sample matrices. Nevertheless, greener analytical approaches for CDN estimation are scarce in the literature. As a result, this study was designed to develop and validate a stability-indicating greener “high-performance thin-layer chromatography (HPTLC)” technique for CDN determination in a laboratory-developed formulation. The greener eluent system for CDN detection was ethanol–water (75:25 v/v). At a wavelength of 262 nm, CDN was measured. The greenness scale of the proposed analytical technolog

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3

Satheesha, Babu Birur Kotappa, Rohith Ganapathi Bhatta, and Sadashivaiah Rudragangaiah. "New Stability Indicating LC Method for Novel Antidiabetic Drug Canagliflozin Hemihydrate Quantification; Development and Validation." Pharmaceutical Methods 10, no. 2 (2019): 6. https://doi.org/10.5281/zenodo.14586135.

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Introduction: The present research includes a new RP-HPLC method development and validation of Canagliflozin Hemihydrate (CANAG) a novel antidiabetic drug. The novel analytical method developed was employed for the quantification of CANAG in bulk drug and as an Active Pharmaceutical Ingredient (API) in tablet formulation. Methods: The present study utilized HPLC instrument (Shimadzu) comprises of ultraviolet detector and COSMICSIL 100 C18 (250 × 4.6 mm) 5 µm column. The mobile phase consists of acetonitrile: water (70:30%v/v) of pH 3.0±0.05 adjusted by addition of ortho-phos

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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 le

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Sonal, Vaishnav H. Dr Vinay C.Darji Jaymin G.Patel Bhumi patel. "STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TIAGABINE HYDROCHLORIDE IN TABLET." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2836–28641. https://doi.org/10.5281/zenodo.1226742.

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A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for estimation of Tiagabine Hydrochloride in their dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Tiagabine Hydrochloride. in their dosage form has been developed. The separation was achieved by column C18 (250mm x 4.6 mm) Hypersil BDS and Buffer (pH 4.5): Methanol (85:15 % v/v) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 260 nm. Retention times of Tiagabine Hydrochloride were found t

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6

Ghante, Minal, Pooja Siddheshware, Vidhya Bhusari, Sanjay Sawant, Vasundhara Sawant, and Preeti Kulkarni. "STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ELIGLUSTAT TARTRATE." Indian Drugs 59, no. 04 (2022): 57–59. http://dx.doi.org/10.53879/id.59.04.12344.

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For determination of eliglustat tartrate, a new, specific, simple, accurate (recovery) and precise stability indicating HPLC method has been developed and validated according to ICH Q2(R1) guidelines. The HPLC method was developed using acetonitrile: 0.1 % orthophosphoric acid 40:60 (V/V) as mobile phase, with pH of mobile phase adjusted to 3.0. The column used was HiQSil C-18 (250 mm x 4.6 mm, 5 μm) as stationary phase at a flow rate of 0.7 mL min-1. Retention time for eliglustat tartarate was found to be 5.9 min. The eluted compounds were detected using a PDA detector. The drug was subjected

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7

Mrinalini, C. Damle* and Shital P. Ghode. "STABILITY INDICATING CHROMATOGRAPHIC METHOD FOR ESTIMATION OF BEPOTASTINE BESILATE." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 06 (2018): 5222–28. https://doi.org/10.5281/zenodo.1289735.

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A Simple, rapid, stability indicating HPTLC method has been developed for estimation of bepotastine besilate. HPTLC separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 using mobile phase as chloroform : methanol. Bepotastine besilate gave sharp peak at RF 0.53 ±0.03 at 225nm.calibration curve was linear in range 5-25ug/band for bepotastine besilate. Stress degradation study was carried out according to ICH guidelines Q1A (R2) and the method was validated as per ICH guideline.

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8

Mehta, Tushar N., Gunta Subbaiah, and Kilambi Pundarikakshudu. "Determination of Cefdinir by a Stability-Indicating Liquid Chromatographic Method." Journal of AOAC INTERNATIONAL 88, no. 6 (2005): 1661–65. http://dx.doi.org/10.1093/jaoac/88.6.1661.

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Abstract A simple, fast, specific, stability-indicating, and precise reversed-phase liquid chromatographic method was developed for the determination of Cefdinir in its different dosage forms, i.e., capsules and suspensions. The method was developed and optimized by analyzing the placebo preparation, formulations, and degraded samples of the drug substance according to the International Conference on Harmonization. The proposed method can successfully separate the drug from degradation products formed under stress conditions along with pharmaceutical ingredients such as preservatives. The deve

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9

Amareshwar, Shabada Nikhat Fatima Humera Badar Syeda Saba Sultana. "DETERMINATION OF PAZOPANIB HYDROCHLORIDE IN SOLID DOSAGE FORM BY RP-HPLC METHOD: DEVELOPMENT AND VALIDATION." Indo American Journal of Pharmaceutical Sciences 04, no. 11 (2017): 4094–99. https://doi.org/10.5281/zenodo.1048471.

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A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Pazopanib hydrochloride in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The aim of this paper was to develop and validate the stabi

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Purvasha, S. Khot* Jaymin Ghanshyambhai Patel Bhumi Rajdevbhai Patel. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF LERCANIDIPINE HYDROCHLORIDE AND ENALAPRIL MALEATE IN COMBINATION." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 3144–51. https://doi.org/10.5281/zenodo.1237984.

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Stability indicating RP-HPLC method for simultaneous estimation of Lercanidipine Hydrochloride and Enalapril Maleate in their Combined Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Lercanidipine HCl and Enalapril Maleate in their combined dosage form. The separation was achieved by column C18 (250mm x 4.6 mm) Hypersil BDS and Buffer (pH 5.0): Methanol (30:70 % v/v) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 233 nm. Retention time of Lercanidipine HCl and Enalapril Ma

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11

Dr., Rina B. Patel, Harsha U. Patel Dr., and Patel Unnati. "Development and validation of stability indicating rp-hplc method for the estimation of cabozantinib in pharmaceutical dosage form." International Journal of Research and Analytical Reviews 7, no. 4 (2022): 892–907. https://doi.org/10.5281/zenodo.6784323.

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A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic (RPHPLC) method was developed for the estimation of Cabozantinib, using a reversed-phase C18 column (250 mm × 4.6 mm, 5 µm) a mobile phase consisting of 0.1% Formic acid:acetonitrile:methanol (35:33:32 v/v), at a flow rate of 1.0 mL/min and ultraviolet detection at 244 nm. The retention time of cabozantinib was found to be 6.03 min. Linearity was established in the range of 100- 500 μg/mL with correlation coefficients 0.990. The percentage recoveries of cabozantinib were

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Kulkarni, Pankaj N., C. K. Jadhav, A. S. Nipate, Alaknanda M. Dodake-Supekar, and C. H. Gill. "Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone." Asian Journal of Chemistry 32, no. 3 (2020): 587–91. http://dx.doi.org/10.14233/ajchem.2020.22462.

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A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excelle

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13

Pandya, Charu P., and Sadhana J. Rajput. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD RP-HPLC METHOD OF ACOTIAMIDE." International Journal of Pharmacy and Pharmaceutical Sciences 10, no. 9 (2018): 1. http://dx.doi.org/10.22159/ijpps.2018v10i9.24925.

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Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of acotiamide in presence of its degradation products.Methods: An isocratic RP-HPLC method has been developed using C-8 Thermo Hypersil BDS Column (250 x 4.6 mm i.d., 5µparticle size) with the mobile phase composition of acetonitrile: 0.1 % triethylamine in 0.2% formic acid (30: 70) at column oven temperature of 40 °C. The flow rate was 1.0 ml min-1 and effluent was detected at 282 nm. The method was validated in terms of linearity, accuracy,

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14

Hanaa, Saleh Gamal H. Ragab Mohammed A. Othman. "STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF DACLATASVIR IN PURE AND TABLETS DOSAGE FORMS." iajps,csk publications 03, no. 12 (2017): 1565–72. https://doi.org/10.5281/zenodo.236131.

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A sensitive, simple, selective and accurate HPLC method was developed and validated for analysis of antiviral drug Daclatasvir (BMS-790052, DCV) in pure form and in tablet dosage form in the presence of its degradation products. The chromatographic separation achieved by isocratic elution on Hypersil BDS C18, 4.6×150 mm, 5µm column at 25˚c. The mobile phase was a mixture of 0.05M Potassium dihydrogen phosphate (pH-4.5) and acetonitrile in ratio of 50:50 (v/v). The injection volume was 10µl. The flow rate was 1ml/ minute. The detection wavelength was 320 nm. The developed method was validated a

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15

Khanvilkar, Vineeta. "Stability indicating assay method for estimation of Empagliflozin using HPTLC." Journal of Medical Pharmaceutical and Allied Sciences 14, no. 1 (2025): 7017–23. https://doi.org/10.55522/jmpas.v14i1.6782.

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A planer chromatographic method capable of indicating the stability of the empagliflozin was developed and validated. Separations were achieved on the silica gel 60F254 as the planar stationary phase and a solvent mixture comprising of Chloroform, Toluene, Methyl alcohol, and Methanolic acid mixed in a proportion of 8:4:2:0.1 v/v/v/v. Examination of the band developed for empagliflozin indicated a densito metric value with an retardation factor of 0.33±0.02. The calibration data analysis through linear regression showed a statistically significant correlation (R2 > 0.990) between peak area

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16

Manjrawala, Mitali, Srinivasarao V. N. Divvela, and Rakesh Kumar. "Validated RP-HPLC Stability Indicating Method of Anti-Diabetic Active Pharmaceutical Ingredient; Saxagliptin Hydrochloride Dihydrate." DER PHARMA CHEMICA 13, no. 3 (2021): 5. https://doi.org/10.5281/zenodo.11071036.

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A simple and precise stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of related substances of Saxagliptin drug substance. The method was developed to separate possible degradation and process related impurities. Chromatographic condition was carried out on in Zorbax SB-C8, 150 mm x 4.6 mm, 5µm HPLC column with prepared buffer solution 1.0 ml of ortho phosphoric acid mixed with 0.1% of sodium dihydrogen phosphate solution, mix buffer solution and acetonitrile in ratio of 70:30(%v/v) used as mobile

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17

Manjrawala, Mitali, N. Divvela Srinivasarao V, and Rakesh Kumar. "Validated RP-HPLC Stability Indicating Method of Anti-Diabetic Active Pharmaceutical Ingredient; Saxagliptin Hydrochloride Dihydrate." Der Pharma Chemica 13, no. 3 (2021): 5. https://doi.org/10.5281/zenodo.14722741.

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A simple and precise stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of related substances of Saxagliptin drug substance. The method was developed to separate possible degradation and process related impurities. Chromatographic condition was carried out on in Zorbax SB-C8, 150 mm x 4.6 mm, 5µm HPLC column with prepared buffer solution 1.0 ml of ortho phosphoric acid mixed with 0.1% of sodium dihydrogen phosphate solution, mix buffer solution and acetonitrile in ratio of 70:30(%v/v) used as mobile

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18

Ojha, Shweta Dineshchandra* Dr Vinay C. Darji Jaymin Patel Bhumi Patel. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ACOTIAMIDE HYDROCHLORIDE HYDRATE IN TABLET DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2563–71. https://doi.org/10.5281/zenodo.1219741.

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A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for Acotiamide HCl Hydrate In its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Acotiamide HCl Hydrate in its Pharmaceutical Dosage Form has been developed. The separation was achieved by Hypersil BDS C18 (25 cm × 0.46 cm) 5μ, column and Water (pH 4.5): Methanol: TEA (45:55:0.1) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 222 nm. Retention time of Acotiamide HCl Hydrate was found to be

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C., Vijitha P. Vivek Sagar* T. Ravi Chander. "METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ITRACONAZOLE AND TERBINAFINE BY RP-HPLC METHOD IN ITS PURE AND TABLET DOSAGE FORM." Journal of Scientific Research in Pharmacy 8, no. 11 (2019): 99–102. https://doi.org/10.5281/zenodo.6979728.

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ABSTRACT A simple, Accurate, precise method was developed for the simultaneous estimation of the Itraconazole and Terbinafine in Tablet dosage form. Chromatogram was run through Symmetry C18 (150 x 4.6 mm, 3.5m) Mobile phase containing Ammonium Acetate and Methanol taken in the ratio 35:65 was pumped through column at a flow rate of 1.6 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 256.0nm. Retention time of Itraconazole and Terbinafine were found to be 2.804 min and 3.875 min. %RSD of the Itraconazole and Terbinafine were and found to be 0.99 and 0.42 respe

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Y, Rajesh Babu, and Appalaraju N. "Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Imatinib Mesylate." International Journal of Current Pharmaceutical Review and Research 8, no. 1 (2017): 56–59. https://doi.org/10.5281/zenodo.12678433.

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The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination ofImatinib mesylate in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicatingRP-HPLC method has been developed for the determination of Imatinib mesylate in bulk drug and pharmaceutical dosageform, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min withan injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correl

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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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Ahmad, Iqbal, Syed Haider Abbas, Zubair Anwar, et al. "Stability-Indicating Photochemical Method for the Assay of Riboflavin: Lumichrome Method." Journal of Chemistry 2015 (2015): 1–8. http://dx.doi.org/10.1155/2015/256087.

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A stability-indicating photochemical method for the assay of riboflavin (RF) in photodegraded samples and aged vitamin preparations has been developed. It is based on photochemical conversion of RF to lumichrome (LC) in alkaline solution under controlled conditions of light intensity, temperature, pH, time of exposure, and distance. Under these conditions about two-thirds of RF is converted to LC and on the basis of the RF : LC ratio the concentration of RF can be determined in degraded solutions. The method involves the extraction of photolyzed solutions of RF (pH 2.0) with chloroform and det

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Chandan, Nakum*¬ Harpal Makwana Vaishali Karkhanis Hina Bagada. "Stability Indicating Assay Method Development and Validation of HPTLC Method for Estimation of Prochlorperazine maleate in Bulk and Tablet Dosage Form." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 1957–72. https://doi.org/10.5281/zenodo.15057985.

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Prochlorperazine maleate is an Antiemetic and Antipsychotic Tranquilizer. It is used for the treatment of severe nausea and vomiting, as well as short-term management of psychotic disorders such as generalized non-psychotic anxiety and schizophrenia. An extensive literature surveys reveals that various analytical methods have been reported for the estimation of Prochlorperazine maleate in API and pharmaceutical dosage form. So, it was thought to develop simple, precise, accurate and specific stability indicating HPTLC method for the estimation of Prochlorperazine maleate in API & pharmaceu

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Shantier, Shaza W., Elrasheed A. Gadkariem, Mohamed O. Adam, and Magdi A. Mohamed. "Development of Stability-Indicating Methods for Cefquinome Sulphate." International Journal of Biomedical Science 9, no. 3 (2013): 162–67. http://dx.doi.org/10.59566/ijbs.2013.9162.

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The degradation behavior of cefquinome sulphate in alkaline medium at different temperatures was investigated using both first derivative spectrophotometric and HPLC methods. The drug degradation was found to be pH and temperature dependant. The pH-rate profile indicated a first order dependence of Kobs on [OH-] at pHs ranging between 9 and 11. Arrhenius plot obtained at pH 10 was linear between 65° and 100°C. The estimated activation energy of the hydrolysis was found to be 21.1 kcal mol-1. Stability-indicating thin-layer chromatographic method for the separation of the drug and its alkaline

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Vinayak, A. katekar, P. Kothari Prafful, S. Kawarkhe Swapnil, P. Surung Manish, and B. Akotkar Vaishnavi. "A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin." GSC Biological and Pharmaceutical Sciences 24, no. 1 (2023): 310–18. https://doi.org/10.5281/zenodo.8265469.

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Metformin HCl and empagliflozin are oral antidiabetic medications that help control blood sugar levels. A simple, precise, rapid, accurate, sensitive, specific, and stable RP-HPLC method was developed and validated for the simultaneous determination of Metformin and Empagliflozin in drug bulk form and drug dosage. This new RP-HPLC method is superior to formal reversed-phase HPLC with reduced solvent usage, retention time, resolution, and cost. Upper region separation was performed on a Waters HPLC system equipped with a PDA detector and autosampler. Both Metformin and Empagliflozin undergo str

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Rarokar, Nilesh R., and Pramod B. Khedekar. "Stability indicating RP-HPLC method development for docetaxel trihydrate." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 525–28. http://dx.doi.org/10.22270/jddt.v9i4-s.3362.

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The purpose of present study was to develop RP-HPLC method for estimation of docetaxel trihydrate which should be a suitable, simple, precise, accurate, robust, and reproducible. The samples were assayed by the Shimadzu HPLC instrument - LC-20AD (Japan) equipped with Shimadzu SPD-M20A UV-VIS detector operated at wavelength of 230 nm. The binary gradiant pump was used for the analytical method development. The reverse phase stainless steel column (150 × 4.6 mm) packed with 5 μm particles (C-8, LiCrosphore® 100, Germany) was used to take chromatograph. A mobile phase consisting of acetonitrile/p

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Kulkarni, Rupesh, and Mahesh Palled. "Stability Indicating UV Spectrophotometric Method for Loxoprofen Sodium: Method Development and Validation." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 14, no. 04 (2023): 874–78. http://dx.doi.org/10.25258/ijpqa.14.4.08.

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Loxoprofen sodium was analyzed using UV spectrophotometry, and the method was designed and validated in the present study in accordance with ICH Q2 recommendations. Loxoprofen sodium’s stress degradation behavior was investigated using a newly discovered technique. Analysis was carried out at 223 nm by using distilled water as solvent. Stress degradation of drug was studied at acidic, basic and oxidative conditions. With a correlation coefficient of 0.999, linearity was found between 5 and 25 μg/mL. Intraday and interday precision studies showed RSD values of <0%, demonstrating the accuracy

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Sagar, Uttam Kumbhar*, and Dounde Swapnil. "A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UV METHOD FOR CARVEDILOL." World Journal of Pharmaceutical Science and Research 4, no. 2 (2025): 748–57. https://doi.org/10.5281/zenodo.15274436.

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The present study describes the development of a new rapid, simple, sensitive and reproducible UV Spectrophotometry RP-HPLC, HPTLC method for the analysis of Carvedilol that offer certain advantages in its simplicity and sensitivity and applicable in routine analysis. It also describes the development of validation work as per ICH guidelines recommended by the Food and Drug Administration (FDA) of the United States. In order to develop a RP-HPLC, HPTLC, UV effective most of the effect should be spent in method development and optimization as this will improve the final method performance. A we

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Rezk, Mamdouh R., Mostafa A. Shehata, Marwa F. Mohamed, and Faten Abdel Aziz Fathalla. "Stability Indicating Determination of Human Growth Hormone by Novel SE–LC Method." Journal of AOAC INTERNATIONAL 99, no. 5 (2016): 1266–72. http://dx.doi.org/10.5740/jaoacint.16-0165.

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Abstract A selective, rapid size-exclusion chromatographic method was developed and validated for the separation of the human growth hormone (hGH) somatropin from its high-molecular-weight aggregates. Separation was achieved using a nontoxic mobile phase compared with the official method of the European Pharmacopoeia that uses 2-propanol in a mobile phase. The developed method used a YMC-Pack Diol (YMC Karasuma, Kyoto, Japan; 300 × 8.0 mm, 5 μm) analytical column. The mobile phase was formed with a pH 7phosphate buffer that was pumped at a flow rate of 1 mL/min with UV detection at 214 nm. The

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Ramadan, Nesrin K., Afaf O. Mohamed, Sara E. Shawky, and Maissa Y. Salem. "Different Stability-Indicating Chromatographic Techniques for the Determination of Netobimin." Journal of Analytical Methods in Chemistry 2012 (2012): 1–8. http://dx.doi.org/10.1155/2012/754650.

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Two simple, accurate, and sensitive methods were developed for the determination of netobimin in the presence of its degradation product. Method (A) was an HPLC method, performed on C18 column using acetonitrile/methanol/0.01 M potassium dihydrogen phosphate (56 : 14 : 30 by volume) as a mobile phase with a flow rate of 0.5 mL/min. Detection was performed at 254 nm. Method (B) was a TLC method, using silica gel 60 F254plates; the optimized mobile phase was toluene/methanol/chloroform/ammonium hydroxide (5 : 4 : 6 : 0.1 by volume). The spots were scanned densitometrically at 346 nm. Linearity r

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Janvi, Chauhan1 Dr. Hina Bagada*2. "Development And Validation of a Simple, LCMS Compatible New Assay Method for The Simultaneous Estimation of Anti-Diabetic Drugs Metformin, Sitagliptin and Glimepiride." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 306–18. https://doi.org/10.5281/zenodo.15332855.

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Tianeptine sodium is widely used as an antidepressant agent; hence it is used to treat depression and anxiety. Aim or Objective: Development of a stability-indicating HPTLC Method for the determination of Tianeptine Sodium in bulk and tablet Form. The objective of this study is to establish a simple, precise, and accurate stability-indicating high-performance thin-layer chromatography (HPTLC) method for the determination of tianeptine sodium in bulk and tablet dosage forms. Materials and Methods: The HPTLC method was developed using chromatographic plates pre-coated with silica gel G60 F254. T

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Shivam, Jadhav* Sanket Deshmukh Shailesh Deshmukh Shivam Gayakwad Abhishek Nagre Shahebaz Deshmuk Dr. R. H. Kale. "Development And Validation of a Simple Stability Indicating High Performance Liquid Chromatographic Method for The Determination of Miconazole Nitrate in Bulk and Cream Formulations." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3239–48. https://doi.org/10.5281/zenodo.15464309.

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A simple, accurate, and stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of miconazole nitrate in both bulk drug and cream formulations. Chromatographic separation was achieved using a C18 column with a mobile phase comprising acetonitrile and phosphate buffer in an optimized ratio. The method demonstrated excellent linearity, precision, accuracy, and robustness in accordance with ICH guidelines. Forced degradation studies were performed under various stress conditions, including acidic, basic, oxidative, thermal, and

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Athavia, Birva A., Zarna R. Dedania, Ronak R. Dedania, S. M. Vijayendra Swamy, and Chetana B. Prajapati. "STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF VILAZODONE HYDROCHLORIDE." International Journal of Current Pharmaceutical Research 9, no. 4 (2017): 123. http://dx.doi.org/10.22159/ijcpr.2017v9i4.20975.

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Objective: The aim and objective of this study was to develop and validate Stability Indicating HPLC method for determination of Vilazodone Hydrochloride.Methods: The method was carried out on a Phenomenex, C18 (250x4.6 mm, 5 µm) Column using a mixture of Acetonitrile: Water (50:50v/v), pH adjusted to 3.3 with Glacial Acetic Acid for separation. The flow rate was adjusted at 1 ml/min and Detection was carried out at 240 nm.Results: The retention time of vilazodone hydrochloride was found to be 2.3 min. The calibration curve was found to be linear in the range 25-75µg/ml with a correlation coef

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Dr., G. Nagaraju, Teena Lavdya, Sirisha V., and Hareesh Dara Dr. "SIMULTANEOUS ESTIMATION OF IVACAFTOR AND LUMACAFTOR IN TABLET DOSAGE FORM BY RP-HPLC METHOD." Journal of Pharma Research 11, no. 6 (2022): 85–90. https://doi.org/10.5281/zenodo.14233059.

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<strong>Abstract</strong> <strong>A</strong> simple, accurate, and precise method was developed for the simultaneous estimation of Lumacaftor and Ivacaftor in tablet dosage form. The method uses a C18 column with a mobile phase of 0.1% triethylamine in acetonitrile. The retention times of Lumacaftor and Ivacaftor were 2.269 and 3.164 minutes, respectively. The %RSD for both drugs was less than 1%, and the %recovery was 100% for both drugs. The LOD and LOQ values were 0.56 and 1.71 µg/ml for Lumacaftor, and 0.07 and 0.11 µg/ml for Ivacaftor. The method was validated according to ICH

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Nimje, Hemlata M., and Meenakshi N. Deodhar. "STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DACLATASVIR IN PHARMACEUTICAL DOSAGE FORM." INDIAN DRUGS 58, no. 4 (2021): 56–62. http://dx.doi.org/10.53879/id.58.04.11662.

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A simple, specific, precise, and accurate stability-indicating assay method using high performance thinlayer chromatography (HPTLC) is described for estimation of daclatasvir dihydrochloride (DCV) in bulk drug and in the tablet dosage form. The separations were achieved on prepared TLC plates precoated with silica gel 60 F254. The mobile phase developed and optimized for bringing out the separation involves toluene: methanol in the ratio of (6:4 V/V). The densitometric scanning wavelength selected was 312.0 nm. The compact bands of DCV were obtained at RF value of 0.702±0.032. The method devel

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Salem, Maissa Y., Nesrin K. Ramadan, Azza A. Moustafa, and Mohamed G. El-Bardicy. "Stability-Indicating Methods for the Determination of Disopyramide Phosphate." Journal of AOAC INTERNATIONAL 89, no. 4 (2006): 976–86. http://dx.doi.org/10.1093/jaoac/89.4.976.

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Abstract Four methods were developed for the determination of intact disopyramide phosphate in the presence of its degradation product. In the first and second methods, third-derivative spectrophotometry and first derivative of the ratio spectra were used. For the third-derivative spectrophotometric method, the peak amplitude was measured at 272 nm, while for the derivative ratio spectrophotometric method, disopyramide phosphate was determined by measuring the peak amplitude at 248 and 273 nm. Both methods were used for the determination of disopyramide phosphate in the concentration range 12.

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Saad, Javed Shaikh*, and Daunde Swapnil. "A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UV METHOD FOR VILDAGLIPTIN." World Journal of Pharmaceutical Science and Research 4, no. 2 (2025): 899–909. https://doi.org/10.5281/zenodo.15302742.

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The present study describes the development of a new rapid, simple, sensitive and reproducible UV Spectrophotometry RP-HPLC, HPTLC method for the analysis of Vildagliptin that offer certain advantages in its simplicity and sensitivity and applicable in routine analysis. Vildagliptin is an antidiabetic agent, belongs to the dipeptidyl peptidase IV (DPP-4) inhibitors. The method employs measurement of absorbance at the wavelength of maximum absorptions of vildagliptin using water as a solven. In order to develop a RP-HPLC, HPTLC, UV effective most of the effect should be spent in method developm

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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

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Rinkal, M. Patel *. Jaymin Ghanshyambhai Patel Bhumi Rajdevbhai Patel. "STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF OXYCODONE HCL AND NALTREXONE HCL IN CAPSULE." Journal of Scientific Research in Pharmacy 8, no. 4 (2019): 42–47. https://doi.org/10.5281/zenodo.2652396.

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<strong><em>ABSTRACT</em></strong> <em><strong>A</strong>reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Oxycodone HCl and Naltrexone HCl in Their Combined Dosage Form. The separation was achieved by LC- 20 AT C<sub>18 </sub></em><em>(250mm x 4.6 mm x 2.6 µm) </em><em>column and Buffer (Potassium Phosphate, pH 4.0): Methanol (75:25) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 248 nm. Retention time of Oxycodone HCl and Naltrexone HCl were found to be 3.427 min and 5.967 min respectively. The metho

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Shelke, Ashwini, Pooja Surwae, Atul R. Bendale, Laxmikany Borse, and Anil G. Jadhav. "Method stability indicating method development and validation for emtricitabina by UV spectroscopic and RP-HPLC methods." International Journal of Pharmaceutical Chemistry and Analysis 9, no. 1 (2022): 10–16. http://dx.doi.org/10.18231/j.ijpca.2022.002.

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Emtricitabine (commonly called FTC, systematic name 2 & 3’-dideoxy-5-fluoro-3-thiacytidine) is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection in adults and children. The UV analysis of the drug was carried out on the 240nm wavelength. A simple, sensitive and accurate RP-HPLC method has been developed& validated for the determination of Emtricitabine in bulk formulation. Present method shows high sensitivity with linearity 10 to 50µg/ml (r2 = 0.9991). Various parameters according to ICH guidelines are followed for validating and tes

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Patel, Jitesha, Parin Chokshi, and Rajashree Mashru. "Validation of Stability Indicating Method and Degradation Kinetic Study of Apremilast." Journal of Drug Delivery and Therapeutics 10, no. 2 (2020): 76–85. http://dx.doi.org/10.22270/jddt.v10i2.3964.

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A novel stability indicating RP- HPLC method was developed for the estimation of Apremilast in bulk and marketed formulation. Separation was achieved by using Shimadzu HPLC Analytical Technologies Limited C18 (250 mm x 4.6 mm, 5µm) as stationary phase. The optimized mobile phase consist of potassium dihydrogen ortho phosphate (pH-3.2): acetonitrile in ratio of 40:60 %v/v with flow rate of 1mL/min by using methanol as diluent. Retention time of Apremilast was found to be 5.4 min which was estimated at wavelength 360nm. Linearity of Apremilast was observed in the concentration range of 50-400µg/

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Srinivasan, V., H. Sivaramakrishnan, and B. Karthikeyan. "Stability-Indicating RP-HPLC Method for Assay of Silver Lactate." E-Journal of Chemistry 8, no. 2 (2011): 483–90. http://dx.doi.org/10.1155/2011/234640.

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A simple, economic and time-efficient stability-indicating, reverse-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for analysis of silver lactate in the presence of degradation products generated by decomposition. When silver lactate was subjected to acid hydrolysis, base hydrolysis, oxidative, photolytic, humidity and thermal stress, degradation was observed during base hydrolysis, oxidation, humidity and thermal stress. The drug was found to be stable to other stress conditions. Successful chromatographic condition of the drug from the degradation products

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C. Damle, Mrinalini, and Nivedita B. Pawar. "STABILITY INDICATING HPLC METHOD FOR SOFOSBUVIR AND DACLATASVIR IN COMBINATION." Indian Drugs 59, no. 10 (2022): 74–79. http://dx.doi.org/10.53879/id.59.10.12506.

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Direct acting fixed dose combination of sofosbuvir and daclatasvir to treat the viral hepatitis C disease is available in the market. So, a precise and robust stability indicating HPLC method for sofosbuvir and daclatasvir was developed. The SunQ C18 column (250 x 4.6 mm) was used for chromatographic separation with mobile phase consisting of 0.03 mM potassium dihydrogen phosphate buffer (pH 7): ACN (50: 50V/V). Optimised method satisfies the system suitability parameters with good resolution with 4.9 min Rt of sofosbuvir and 7.6 min Rt of daclatasvir. The method was validated as per ICH guide

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Sudhakar Babu, Kondru, Venkataramanna Madireddy, and Venkata Somaraju Indukuri. "Degradation Pathway for Eplerenone by Validated Stability Indicating UP-LC Method." ISRN Pharmaceutics 2012 (October 14, 2012): 1–8. http://dx.doi.org/10.5402/2012/251247.

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Degradation pathway for eplerenone is established as per ICH recommendations by validated and stability-indicating reverse phase liquid chromatographic method. Eplerenone is subjected to stress conditions of acid, base, oxidation, and thermal and photolysis. Significant degradation is observed in acid and base stress conditions. Four impurities are studied and the major degradant (RRT about 0.31) was identified by LC-MS and spectral analysis. The stress samples are assayed against a qualified reference standard and the mass balance is found close to 99.5%. Efficient chromatographic separation

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Patil, Priti S., Purnima D. Hamrapurkar, Mitesh D. Phale, Masti I. Desai, and Sandeep B. Pawar. "Study of Doxofylline and its Degradation Products in Bulk Drug by a Newly Developed Stability-Indicating HPLC Method." Journal of AOAC INTERNATIONAL 96, no. 4 (2013): 765–70. http://dx.doi.org/10.5740/jaoacint.10-239.

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Abstract The purpose of this work was to study the stability behavior of doxofylline under different stress conditions and to develop a sensitive stability-indicating HPLC assay method. The stress conditions applied included heat, moisture, acid-base hydrolysis, oxidation, and UV light. The drug was particularly labile under oxidative and thermal stress conditions, with 58.40 and 53.90% degradation, respectively. Good resolution of drug from degradation products formed under stress conditions was achieved on a C18 column using 10 mM KH2PO4 buffer solution (pH 6) methanol (40 + 60, v/v) as the

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R., Sairam Aditya, Tengli Anandkumar, Ramesha, S. Chandan R., Anupama K., and M. Gurupadayya B. "Development and Validation of Stability Indicating UFLC Method for the Estimation of Anti-spasmodic Drug - Valethamate Bromide." Journal of Advances in Medical and Pharmaceutical Sciences 13, no. 3 (2017): 1–12. https://doi.org/10.9734/JAMPS/2017/26825.

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A stability indicating Ultra-Fast Liquid Chromatography (UFLC) method has been developed to estimate valethamate bromide (V&B) in tablet dosage forms and to separate analyte from other degradants and to carryout forced degradation studies. The chromatographic separation was achieved by using phenomenex kinetex 5 μ C<sub>18</sub> 100A (250x 4.6 mm) column with a flow rate of 1 mL/min in an isocratic mode with the mobile phase consisting of 0.05 M potassium dihydrogen phosphate buffer pH 7.5 (adjusted with potassium hydroxide) and acetonitrile in the ratio of 50:50. The eluents were monitore

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Mohammad, Mujeeb Gulzar Khan, and Arun Shirkhedkar Atul. "Validated Stability-indicating NP-HPTLC/Densitometry Method for the Assay of Zolpidem Tartrate in Pharmaceutical Dosage Form." Pharmaceutical Methods 8, no. 2 (2017): 87–91. https://doi.org/10.5281/zenodo.14856315.

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Background: A simple, precise stability-indicating Normal- Phase Thin-Layer Chromatography (NP- TLC)/ Densitometry method has been studied for estimation of zolpidem tartrate in bulk and in tablet formulation. Method: The chromatographic separation was accomplished on aluminium backed precoated silica gel 60 F254S as the stationary phase using Ethyl acetate: Methanol: triethylamine (9: 1: 0.3 v/v) as mobile phase. Densitometric analysis of zolpidem tartrate was achieved at λ max 293 nm. The method was validated for robustness, precision and accuracy. Stress degradation of zolpidem tartr

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Santosh, V. Gandhi* Vaishali P. Shevale and Ganesh B. Choudhari. "DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF TERIZIDONE." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 03 (2018): 1353–61. https://doi.org/10.5281/zenodo.1197068.

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A simple, rapid, sensitive, and linear stability indicating reverse phase HPLC method was developed for estimation of Terizidone. In this method separation was carried out on HiQSil C8 column (250mm*4.6 mm, 5μm) using Ammonium Acetate Buffer pH 3 (adjusted with glacial acetic acid) and methanol (60:40 v/v) as mobile phase at flow rate of 1 ml/min. The quantification was carried out at 264 nm. The retention time (tR) of drug was 7.3± 0.10 min. The method was validated with respect to linearity, precision, assay, accuracy and robustness. The data of linear regression analysis indicated

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Nerkar, Pankaj Padmakar, Sameer Ansari, and Shailesh Chalikwar. "Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide." International Journal of Pharmaceutical Sciences and Nanotechnology 12, no. 5 (2019): 4635–45. http://dx.doi.org/10.37285/ijpsn.2019.12.5.3.

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A simple, isocratic, and accurate reversed phase HPLC method was developed for the quantitative determination of enzalutamide. The chromatographic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5 μm) column using methanol: ammonium acetate buffer pH 4.2 adjusted with glacial acetic acid: (60:40, v/v) as a mobile phase, at a flow rate of 1 ml/min and detection at 236nm. The linear range for enzalutamide were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.998. The retention time was found to be 6.30min. Enzalutamide was subjected to stress conditions hydrolysis (

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Vanaplli, Goutham Kumar, and Sumanta Mondal. "A new stability indicating RP-HPLC method for estimation of brexpiprazole." Journal of Drug Delivery and Therapeutics 9, no. 2-s (2019): 214–22. http://dx.doi.org/10.22270/jddt.v9i2-s.2652.

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A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Brexpiprazole in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, using a mixture of 0.1% acetic acid and methanol (65:35, v/v) as mobile phase with a flow rate of 0.9 mL/min. Detection was carried at 214nm. Linearity was observed over the concentration range of 0.1–250 μg/mL (R2 = 0.9999) with regression equation y = 39617.94x + 3300.8. Brexpiprazole was subjected to stress conditions (acidic, alkaline, oxidation

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