A novel validated RP-UPLC for the simultaneous estimation of Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat and Elvitegravir in tablet dosage form
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Keywords
performance, method, specific
Abstract
The present study provides us a single analytical tool for the determination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate in dosage forms. This method helps us to separate and detect the four active pharmaceutical ingredients in a single run. The objective is to develop and validate a simple Ultraphase liquid chromatography method for the simultaneous determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat in dosage tablets. For this method, an Agilent 1200, high performance liquid chromatography system, Acquity Ethylene Bridged Hybrid technology (BEH) C18, 1.7μ. 100 x 2.1 mm column was used. The gradient program was adjusted at 0.3 ml/min flow rate and 10 μl injection volumes were maintained. Detection wavelength of 260 nnm is found to specific and could able to provide precise area counts for each drug. Calibration curves depicting a proper linearity response from concentration versus area observed for each drug with correlation coefficients of greater than 0.99. The eluted compounds were monitored at 240 nm. The column oven temperature was maintained at 30°. The developed chromatographic method was validated for selectivity, linearity, precision, accuracy, sensitivity, robustness, and system suitability.
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