Abstract

A NEW VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMUTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR IN TABLET DOSAGE FORMS

D. Vinay Kumar* and JVLN Seshagiri Rao

Abstract

A combination of Sofosbuvir and Ledipasvir is used to treat Hepatitis C virus (HCV). A selective, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of these drugs in combined tablet dosage forms. The drugs were resolved on a Kromosil C18 column using Acetonitrile: 0.1% orthophosphoric acid (35:65 v/v) as the mobile phase. The detection wavelength was 272 nm. The retention times obtained for sofosbuvir and ledipasvir were 2.516 & 3.743 min respectively. The linearity ranges were 100-600 & 22.5 - 135 μg/ml respectively with Regression coefficients of 0.999. The % R.S.D. of precision studies was found to be 0.92 & 0.64 respectively. The Accuracy of the proposed method was determined by recovery studies and the mean recovery was 100.16 & 99.78% respectively. The method was also applicable for quantitative analyses of the marketed tablet formulations and in studying stability of the drugs under acidic, alkaline, oxidation, thermal and UV conditions.

Keywords: Sofosbuvir, Ledipasvir, Tablets, Degradation studies, RP-HPLC.