RP-HPLC method development and validation for the estimation of Emtricitabine, Bictegravir and Tenofovir alafenamide in bulk and pharmaceutical dosage form

Abstract

A new simple, accurate, precise RP-HPLC [reverse phase high performance liquid chromatography] method was developed for the simultaneous estimation of the Emtricitabine, Bictegravir and Tenofovir alafenamide in pharmaceutical dosage form. Chromatogram was run through Denali C18 column (150 mm × 4.6 mm, 5 µm); mobile phase containing buffer and acetonitrile in the ratio of 50:50 was pumped through column at a flow rate of 1 ml/min [Buffer: 0.1% at pH 2.2, temperature 30°C]. Optimized wavelength was 272 nm. Retention times of Emtricitabine, Bictegravir and Tenofovir alafenamide were found to be 2.303, 3.219 and 3.754 min respectively. The %RSD of the Emtricitabine, Bictegravir and Tenofovir alafenamide were found to be 0.7, 0.8 and 0.4, respectively. The %recovery was obtained as 99.89%, 100.65% and 100.38% for Emtricitabine, Bictegravir and Tenofovir alafenamide, respectively. This method was accurate, precise and sensitive; hence, could be employed for routine quality control of Emtricitabine, Bictegravir and Tenofovir alafenamide in pharmaceutical industries and drug testing laboratories.