Development and validation of RP-UPLC method for simultaneous estimation of Cobicistat and Darunavir

Madhavi, S.; Rani, A. Prameela

doi:10.5958/0974-360x.2017.00796.x

Cited by 12 publications

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“…Few HPLC works were done previously on single drugs of the present study, in double combinations and also in combination with other drugs were done [9][10][11][12][13][14][15][16][17], but there were no analytical works developed for STR-based tablets containing DRV, COBI, FTC and TAF till date.…”

Section: Discussionmentioning

confidence: 99%

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Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Sakuntala

Rao²,

Carey³

2021

Futur J Pharm Sci

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Background Tablet dosage forms containing combination of darunavir a protease inhibitor, cobicistat a cytochrome P450 3A inhibitor, emtricitabine and tenofovir alafenamide which were nucleoside reverse transcriptase inhibitors were approved by USFDA on 1st July 2018 to suppress the viral load in HIV patients. It can be used as a complete regimen for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 40 kg. An UPLC method was developed, and separation was done on SB C8 column of dimensions 50 × 2.1 × 1.8 μ with mobile phase 0.01 N potassium dihydrogen ortho phosphate (pH-4.8) and acetonitrile in 60:40 ratio, at a flow rate of 0.3 mL/min and an injection volume of 2 μL. The column temperature was maintained at 30 °C, and detection wavelength was 267 nm. The method was validated according to ICH guidelines. Results The retention times were 1.031, 1.341, 1.630 and 2.153 min, and they were linear in the concentration range of 1.25–7.5 μg/mL, 18.75–112.5 μg/mL, 25–150 μg/mL and 100–600 μg/mL for tenofovir alafenamide, cobicistat, emtricitabine and darunavir, respectively. The intraday and interday precisions were found to be within acceptable limits. LOD was found to be 0.06 μg/mL, 0.51 μg/mL, 1.31 μg/mL and 3.01 μg/mL, and LOQ was 0.19 μg/mL, 1.54 μg/mL, 3.96 μg/mL and 9.13 μg/mL for tenofovir alafenamide, cobicistat, emtricitabine and darunavir. The correlation coefficients were found to be more than 0.999, and recovery was more than 99.52% indicating the method was accurate. Forced degradation studies reveal that the drugs are unstable under acidic conditions. The method was simple, accurate, precise, stable and can be analysed in less runtime of 4 min. Conclusions The flexibility, accuracy and precision of the developed method ensure its applicability in routine analysis of tablet dosage forms. Graphical Abstract

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Section: Discussionmentioning

confidence: 99%

“…Literature survey reveals that HPLC analysis was performed to simultaneously determine multiple drug components in STR-based drug products [9][10][11][12][13][14][15][16][17]. To the best of my knowledge, there were no analytical works for the analysis of STR-based tablets containing DRV, COBI, FTC and TAF.…”

Section: Introductionmentioning

confidence: 99%

Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Sakuntala

Rao²,

Carey³

2021

Futur J Pharm Sci

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“…The market is flooded with many drugs for the management of diabetes and it is also prime requirement to have quality medicines a patient have to get relief from increase glucose level. Several methods available to estimate Vildagliptin (VIL) and Dapagliflogin (DAP) by using UV Spectroscopy [1][2][3][4][5], UPLC [6], RP-HPLC [7][8][9][10][11][12][13], UPLC and LC-MS/MS [14][15][16] in individual dosage form and combination with Metformin and Saxagliptin. In the current scenario, regulatory authority also recommend manufacturer to have quantitative and qualitative estimation by sophisticated instrument HPLC.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation and Stability Indicating Method of Vildagliptin And Dapagliflozin by RP-HPLC in Pharmaceutical Dosage Form

2024

Int Internal Med J

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Vildagliptin and Dapagliflozin drugs are used for the management of diabetes.The primary objective of the proposed research was to develop and validate analytical methods for simultaneous quantification of vildagliptin and dapagliflozin in pharmaceutical dosage form. Both the drugs were subjected to force degradation to ensure stability of pharmaceutical products. The HPLC method development was carried out on C18 column (250mm*4.6mm,5µm particle size). The chromatographic separation was achieved by isocratic mode with a mixture of Methanol: 0.01% Trifluoro acetic acid (pH-2.78) in the ratio of 95:05 % v/v as mobile phase. Flow rate was kept at 0.8 ml/min and selected wavelength for estimation was 210 nm. Stress testing with acid, alkaline, oxidative and thermal degradation was performed. The retention time was found to be 2.282 min and 4.070 min for vildagliptin and dapagliflozin, respectively. The drugs response found to be linear with correlation coefficient value was nearly 0.999 for vildagliptin and dapagliflozin with linearity range of 10 – 60 µg/ml. The recoveries from studies were found to be 99.78% and 100.17% for vildagliptin and dapagliflozin respectively. LOD and LOQ were found to be lower, hence the method proved sensitivity. Method was validated as per ICH guideline Q2(R1). Drugs had shown more degradation in oxidative condition, 10.62% and 13.52% for vildagliptin and dapagliflozin, respectively. The proposed method would be successfully applied for the stability indicating, impurity separation, qualitative and quantitative estimation of vildagliptin and dapagliflozin in pharmaceutical dosage form and in process quality control analysis.

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“…Robustness: Robustness of method was studied by a small but deliberate change in chromatographic condition conditions as listed below, and their effect was observed on system suitability 12 . A chromatogram was recorded, and area of darunavir ethanolate and ritonavir was measured.…”

Section: Introductionmentioning

confidence: 99%

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2020

IJPSR

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Development and validation of RP-UPLC method for simultaneous estimation of Cobicistat and Darunavir

Cited by 12 publications

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Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Simultaneous Estimation and Stability Indicating Method of Vildagliptin And Dapagliflozin by RP-HPLC in Pharmaceutical Dosage Form

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