Analytical RP-HPLC method development and validation for simultaneous estimation of Emtricitabine, Tenofovir and Bictegravir

Abstract

The Emtricitabine, Bictegravir and Tenofovir are used to treat Cystic fibrosis treatment. For estimation of this drug in bulk and pharmaceutical dosage form the standard, simple, accurate RP-HPLC method was devoloped, to run the sample column used was Kromasil C18 150×4.6mm,5µ and mobile phase of 0.1%OPA and acetonitrile of 55:45 v/v at a flow rate of 1ml/min, 30°C temperature was maintained, 272.0 nm wavelength was used. The retention times for tenofovir, bictegravir, and emtricitabine were 2.140,2.432, and 2.992 minutes, respectively. Emtricitabine, Bictegravir, and Tenofovir were found to have 1.1, 1.0, and 0.9 percent RSD of method precision respectively. Emtricitabine, Bictegravir, and Tenofovir all recovered 100.24 percent, 100.19 percent, and 100.06 percent of their doses, respectively and LOQ values are 0.93 ppm, 0.34 ppm and 0.23ppm respectively, and LOQ values are 2.80ppm, 1.04, 0.70ppm, respectively, for Emtricitabine, Bictegravir, and Tenofovir.