A NOVEL RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TENOFOVIR ALAFENAMIDE AND EMTRICITABINE IN BULK AND COMBINED TABLET DOSAGE FORMS

kumaraswamy gandla, N Majutha, D Sudheer Kumar

Abstract


The present study accurate and precise RP-HPLC method has been developed for the validated of Tenofovir Alafenamide and Emtricitabine Acyclovir as an internal standard method in its bulk and Combined Tablet dosage forms. Chromatography was carried out system C18 (4.5 x 250mm, 5µm) column using a mixture of Methanol: phosphoric acid buffer adjusted pH  4.5 (70:30 v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 266 nm. The retention time of the Tenofovir alafenamide and Emtricitabine were found 2.1 and 3.4 min and respectively. The method produce linear responses in the concentration range of 10-60 µg/mL of Tenofovir alafenamide and 30- 180 µg/ml of Emtricitabine. The method precision for the determination of assay was below 2.0%RSD. 


Keywords


Internal standard method; Emtricitabine; Tenofovir alafenamide; Acyclovir (internal standard) RP-HPLC; ICH validation; Tablet dosage forms

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