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Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENOFOVIR DISOPROXIL FUMARATE, COBICISTAT, EMTRICITABINE AND ELVITEGRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

N. Khaleel*, Sk. Abdul Rahaman

A new simple, precise, selective, accurate and rapid RP-HPLC stability indicating method had been developed and validated for simultaneous quantitative determination of Tenofovir disoproxil fumarate, Cobicistat, Emtricitabine and Elvitegravir in bulk and pharmaceutical dosage form using Kromasil C18 (250×4.6 mm, 5μm) in isocratic mode. The optimized mobile phase consists of Orthophosphoric acid buffer: Acetonitrile (55:45 %v/v). The flow rate was 1.0 mL/min and eluents were detected at 240 nm using PDA detector. The method was linear in the range of 20 -120 μg/ml for Emtricitabine, 30-180 μg/ml for Tenofovir, 15-90 μg/ml for Cobicistat and 15-90 μg/ml for Elvitegravir. Degradation studies were studied for Tenofovir disoproxil fumarate, Cobicistat, Emtricitabine and Elvitegravir under various stress conditions, all the degradation peaks were resolved effectively using developed method with different retention times. The developed method was validated according to ICH guidelines.