Abstract

ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF VELPATASVIR AND SOFOSBUVIR IN BULK AND IT’S DOSAGE FORM BY RP-HPLC

Dr. P. V. Murali Krishna*, G. Gurunath, Kalyani Peluri and D. Amulya

Abstract

A simple reverse phase liquid Chromatographic method has been developed and subsequently validated for simultaneous determination of Sofosbuvir and Velpatasvir in combination. The separation was carried out using a mobile phase of phosphate buffer (0.05M) pH 7: MeOH (30:70%v/v) (pH was adjusted with orthophosphoric acid) and using methanol as diluent. The column used was Xterra C18 (150 mm x 4.6 mm i.d., 5μm) with flow rate of 1 ml/min using UV detection at 270 nm. The retention times of Sofosbuvir and Velpatasvir were found to be 2.399 and 3.907min respectively. Results of analysis were validated statistically and by recovery studies. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Sofosbuvir and Velpatasvir bulk drug and in its pharmaceutical dosage form.

Keywords: Sofosbuvir and Velpatasvir.