Method Development and Validation of Sofosbuvir and Ledipasvir in API & Its Pharmaceutical dosage forms by RP-HPLC

Shinnde Sandeep*
Department of Pharmaceutical Analysis & Quality Assurance ,SSJ College of Pharmacy,Vattinagulapally, Gandipet, Hyderabad – 500075, Telangana State

A B S T R A C T
Ledipasvir is indicated in patients with hepatitis C virus (HCV) genotype 1 for treatment of chronic hepatitis as a combination therapy, which includes peg interferonalfa and ribavirin. Ledipasvir is a protease inhibitor for HCV NS5A protease, which is required for replication of the virus. SOVALDI is the brand name for sofosbuvir, a nucleotide analog inhibitor of HCV NS5B polymerase. It is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. A novel reversed phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative determination of Ledipasvir and Sofosbuvir in active pharmaceutical ingredients and in its pharmaceutical dosage form by using Inertsil-C18 ODS column as stationary phase and a mobile phase containing a mixture of Methanol: Water (60:40% v/v). The flow rate was 1.0ml/min and effluent was monitored at 254nm and a peak eluted at 2.9min, 3.4min and column oven temperature was maintained ambient. Calibration curve was plotted with a range from 20-80ppm. The developed RP-HPLC method was validated according to the current International Council for Harmonisation (ICH) guidelines for specificity, LOD, LOQ, linearity, accuracy, precision, intermediate precision and robustness. The result of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine analysis of Ledipasvir &Sofosbuvir in bulk drug and in its pharmaceutical dosage form.
Key words: Ledipasvir, Sofosbuvir, RP-HPLC and Validation.