New analytical method development and validation for the simultaneous estimation of velpatasvir and sofosbuvir in pharmaceutical dosage forms

Abstract

A selective and sensitive reverse phase high performance liquid chromatography (RP-HPLC) has been

developed for the separation and quantification of Velpatasvir and Sofosbuvir in tablet dosage form and

validated .The determination was carried out using Thermosil C18 column (250 mm ×4.6 mm id) as a stationary

phase and mobile phase comprised of Methanol: 0.01M Potassium dihrogen orthophosphate buffer in proportion

of 55:45(v/v) with pH adjusted to 7±0.5 by using triethyl amine. The flow rate was 1.0ml/min and the eluent

was monitored at 256nm.The retention time of and Velpatasvir and Sofosbuvir were 2.089 ±0.018 min and

5.327±0.024 min respectively. The Coefficient of correlation and percentage recoveries of Velpatasvir and

Sofosbuvir were 0.9986 and 100.0l % and 0.9994 and 99.98% respectively. The method is validated for

accuracy, Precision, ruggedness and Robustness. The proposed method is successfully applied for the

simultaneous determination of both drugs in commercial tablet preparation. The results of the analysis have

been validated statistically and by recovery studies.