Analytical method development and validation for simultaneous estimation of Cobicistat and Elvitegravir by using RP-HPLC in pure and Pharmaceutical Dosage Forms

Swetha, Vegesna; Prasad, S. V. U. M.; Rani, Y. Asha

doi:10.5958/2231-5675.2017.00024.2

Cited by 6 publications

(1 citation statement)

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“…Various HPLC and HPTLC methods were reported in the literature for the estimation of cobicistat and elvitegravir individually [6][7][8] , simultaneously [9][10] and other antiretroviral drugs [10][11][12][13][14][15][16][17][18][19][20] . The present method is novel and was successfully validated in accordance with ICH guidelines 21 .…”

Section: Fig 2: Chemical Structure Of Elvitegravirmentioning

confidence: 99%

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2019

IJPSR

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A simple, precise, rapid and accurate reverse phase HPLC method was developed for the simultaneous estimation of cobicistat and elvitegravir in the pharmaceutical dosage form. A column of ODS (250mm 4.6mm; i.d and 5µ particle size) was used along with the mobile phase comprising of 0.02M dipotassium hydrogen orthophosphate buffer (pH adjusted to 3.3) and methanol in the ratio of 80:20 (v/v). The flow rate was maintained at 1.0 ml/min and the effluents monitored at 254 nm. The retention time for cobicistat was found to be 2.58 ± 0.3 min and elvitegravir was 3.71 ± 0.3 min. The detection concentration was linear over 125-750 µg/ml for cobicistat and 12.5-75 µg/ml for elvitegravir. Regression equations of cobicistat and elvitegravir were found to be y = 25883x + 19711 and y = 27696x + 6046 respectively with regression coefficient 0.999. The % RSD for Intra and Inter day precision was < 2%. The accuracy of method was validated by recovery studies and found to be significant within acceptable range 98-102%. The developed method was successfully validated in accordance with ICH guidelines. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single RP-HPLC method for the simultaneous quantitative determination of cobicistat and elvitegravir in fixed pharmaceutical dosage form. Hence, this method can be conveniently adopted for routine analysis in quality control laboratories.

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Section: Fig 2: Chemical Structure Of Elvitegravirmentioning

confidence: 99%

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2019

IJPSR

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Quality by Design Adapted Chemically Engineered Lipid Architectonics for HIV Therapeutics and Intervention: Contriving of Formulation, Appraising the In vitro Parameters and In vivo Solubilization Potential

et al. 2020

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Development and validation of UPLC method for simultaneous estimation of Darunavir, Cobicistat, Emtricitabine and Tenofovir alafenamide in bulk drug and pharmaceutical dosage form

Dadi

Gummadi

2023

RJPT

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The main objective of the present study was to develop and validate a multicomponent analysis of Darunavir, Cobicistat, Emtricitabine and Tenofovir alafenamide in bulk drug and pharmaceutical dosage form by ultra-performance liquid chromatography (UPLC). The drugs were separated using HSS C18 (100mm × 2.1mm, 1.8µ particle size) column with mobile phase consisting of potassium dihydrogen phosphate, pH adjusted to 5.4 and acetonitrile in the composition of 60:40 %v/v operated in isocratic mode at a flow rate of 0.3 ml/min. The column temperature maintained at 30˚C and detection wavelength used was 260 nm. The retention time for Darunavir was found to be 1.04min, for Cobicistat it was 1.82 min, for Emtricitabine it was 2.28 min and for Tenofovir it was found to be 1.39min. The developed method was validated in accordance to the ICH guidelines. The method obeyed Beer’s law in the concentration range of 50 µg/ml- 300µg/ml for Darunavir, 7.5 µg/ml – 45 µg/ml for Cobicistat, 25µg/ml - 150µg/ml for Emtricitabine and 0.625 µg/ml – 3.75µg/ml for Tenofovir alafenamide, with correlation coefficient of 0.999. The % relative standard deviation for all the drugs was found to be less than two indicating the method to be precise. The mean % recovery was found to be within the limits for all the drugs indicating that the method to be accurate. The method was also found to be specific, robust and stable. From the forced degradation studies, it was concluded that the drugs were found to be stable when exposed to different stress conditions as the net degradation was found within the acceptance criteria. The developed method for the multicomponent analysis of Darunavir, Cobicistat, Emtricitabine and Tenofovir alafenamide using UPLC can be used for quality control and routine analysis in bulk drug and pharmaceutical dosage form.

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Analytical method development and validation for simultaneous estimation of Cobicistat and Elvitegravir by using RP-HPLC in pure and Pharmaceutical Dosage Forms

Cited by 6 publications

References 0 publications

Untitled

Untitled

Quality by Design Adapted Chemically Engineered Lipid Architectonics for HIV Therapeutics and Intervention: Contriving of Formulation, Appraising the In vitro Parameters and In vivo Solubilization Potential

Development and validation of UPLC method for simultaneous estimation of Darunavir, Cobicistat, Emtricitabine and Tenofovir alafenamide in bulk drug and pharmaceutical dosage form

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