HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DRUG RELEASE OF LEDIPASVIR AND SOFOSBUVIR IN LEDIPASVIR AND SOFOSBUVIR TABLETS

Analytical scientists of the pharmaceutical industry aimed at developing robust HPLC methods for analysis of generic drug products. This paper deals with HPLC method of analysis for estimation of % drug release of Ledipasvir and Sofosbuvir in Ledipasvir and Sofosbuvir tablets used for the treatment of chronic hepatitis C virus (HCV) infection. For analysis of dual combination drug product, HPLC method uses ‘Zorbax Eclipse Plus C18 100 × 4.6 mm, 3.5 µm’ HPLC column, a combination of buffer pH 3.0 and acetonitrile as mobile phase in gradient mode with UV detection at 260 nm. The method was validated and found to be precise, robust, accurate and linear (in range 9.05 to 54.3 µg/mL and 2.045 to 12.27 µg/mL of Sofosbuvir and Ledipasvir respectively). The method was also found to be specific for blank and placebo solutions. This ensures suitability of the method for simultaneous quantitative determination of % drug release of Ledipasvir and Sofosbuvir in a pharmaceutical formulation. In the pharmaceutical industry, this method can be used for routine as well as stability samples analysis in formulation product.