DEVELOPMENT OF ASSAY METHOD AND FORCED DEGRADATION STUDY OF LEDIPASVIR AND SOFOSBUVIR BY RP-HPLC IN TABLET FORMULATION

Chronic hepatitis C virus (HCV) infection is one of the most common etiologies of liver-related mortality throughout the world. Sofosbuvir and ledipasvir are inhobits HCV NS5B and HCV NS5A polymerase respectively. No published LC-MS/MS and HPLC based methods for simultaneous estimation of ledipasvir and sofosbuvir. Therefore, A stability indicating high performance liquid Chromatographic (HPLC) method was developed and validated for estimation of both drugs. Chromatographic separation was achieved on a C18 column [Xterra, 250 x 4.6 mm, 5μ] utilizing a mobile phase consisting a mixture of 0.1% trifluro acetic acid and methanol in the ratio of 40:60 v/v at a flow rate of 1ml/min with UV detection at 246nm. The retention time of Ledipasvir and Sofosbuvir was 3.13 min and 4.17 min respectively. Good linearity obtained over the range of 25μg/ml to 150μg/ml for Ledipasvir and sofosbuvir. Correlation coefficient was found to be 0.998&0.998 for Ledipasvir& sofosbuvir respectively. The % RSD of precision for Ledipasvir and sofosbuvir was found to be 0.23and 0.86respectively. The % mean recovery was found to be 98.76-99.26% for Ledipasvir and 99.03-100.73.% for sofosbuvir. Thus the validated economical method was applied for forced degradation study of Ledipasvir and Sofosbuvir tablet