DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR IN TABLET DOSAGE FORM

Simple, specific, accurate and precise reversed phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Sofosbuvir and Ledipasvir in tablet dosage form by reversed phase C18 column (Kromasil C18 5μ, 250 mm x 4.6 mm). The sample was analyzed using 0.1% OPA: Acetonitrile in the ratio of 55:45 as a mobile phase at a flow rate of 1.0 ml/min and detection at 230 nm. Calibration curves were linear with correlation coefficient (r2 ) 0.999 over a concentration range of 100-600 µg/mL for Sofosbuvir and 0.999 over a concentration range of 22.5-135 µg/mL for Ledipasvir. The retention time was found to be 6 min. The mean recoveries were found to be 99.10% and 99.30% for Sofosbuvir and Ledipasvir respectively. The relative standard deviation (RSD) was found to be < 2.0% for both drugs. The proposed method was validated and successfully applied to the estimation of Sofosbuvir and Ledipasvir in tablet dosage form. Keywords: Sofosbuvir, Ledipasvir, RP-HPLC, Validation, Stability.