Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and Pharmaceutical Dosage Form

D. Hemalatha, G. Dharmamoorthy*
Department of Pharmaceutical Analysis, Krishna Teja Pharmacy College, Tirupati-517506, A.P, India

ABSTRACT
A simple, Accurate, precise method was developed for the simultaneous estimation of the Ledipasvir and Sofosbuvir in bulk and its  Tablet dosage form. Chromatogram was run through Std Kromosil C₁₈ (150 x 4.6 mm, 5m) column. Mobile phase containing Buffer 0.01N KH₂PO₄: Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 1.0 ml/min. pH 5.4 adjust with orthophosphoric acid. Temperature was maintained at 30°C. Optimized wavelength selected was 220.0 nm. Retention time of Ledipasvir and Sofosbuvir were found to 2.402 min and 3.526 min. Linearity concentrations for Ledipasvir and Sofosbuvir 2.25-13.5µg/ml and 10-60 µg/ml.  %Recovery was obtained as 100.28% and 100.25% for Ledipasvir and Sofosbuvir respectively.%RSD of the Ledipasvir and Sofosbuvir were and found to be 0.4 and 0.7 respectively. LOD, LOQ values obtained from regression equations of Ledipasvir and Sofosbuvir were 0.05, 0.16 and 0.41, 1.23 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
Keywords: Ledipasvir, Sofosbuvir, RP-HPLC