Abstract

A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF VELPATASVIR AND SOFOSBUVIR IN COMBINED TABLET DOSAGE FORMS

Sarath Nalla* and Seshagiri Rao J. V. L. N.

ABSTRACT

A rapid and sensitive stability indicating RP-HPLC method was developed for simultaneous estimation of velpatasvir and sofosbuvir in combined tablet formulations. Chromatography was carried out on a Discovery® C18 HPLC Column (250 x 4.6 mm; 5 particle size) by eluting with a mobile phase consisting of a 60:40 v/v mixture of 0.1% orthophosphoric acid in water and acetonitrile (ACN) at a flow rate of 1.0 mL/ minute. The detection wavelength was set at 240 nm. Accuracy was assessed by using standard addition method. The developed HPLC method was validated with respect to precision, specificity, accuracy, linearity and robustness. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of the analytes under acid, base, peroxide, thermal and photolytic conditions and suitability of the method to resolve the degradation products.

Keywords: Velpatasvir, Sofosbuvir, RP-HPLC, Forced degradation, Method validation.