Simultaneous RP-HPLC method development and it’s validation for estimation of sofosbuvir and velpatasvir in their combined dosage form

Abstract

A new simple and precise simultaneous RP-HPLC method was developed and validated for the identification and analysis of fixed dose combination of Sofosbuvir and velpatasvir in their combined tablet dosage form. The excipients in the tablet form showed no intervention with the analyte chromatograms. The retention time of sofosbuvir was 3.049 minutes and velpatasvir was 4.316 minutes respectively. The developed method was validated for linearity, specificity, accuracy, robustness and ruggedness according to 1CH instructions. The limit of detection were 0.475 ppm and 0.65 ppm and the limit of quantification were 1.44 ppm and 1.98 ppm for Sofosbuvir and Velpatasvir respectively. The drug content assay in the tablet was closer to 100%. All the validated parameters met the acceptance criteria. The developed method can be used in quality control analysis.