RP-HPLC Method Development and Validation for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Bulk and Dosage Forms

Abstract

This study focuses on the development and validation of a stability-indicating RP-HPLC method for the simultaneous estimation of Sofosbuvir and Velpatasvir in bulk and pharmaceutical dosage forms. Sofosbuvir and Velpatasvir are critical antiviral drugs used in the treatment of Hepatitis C, and their accurate quantification is essential for quality control in pharmaceutical manufacturing. The proposed RP-HPLC method offers a simple, rapid, and reliable approach to quantify both drugs with high sensitivity, specificity, and reproducibility. The method was optimized using a Waters Alliance 2695 HPLC system with a Hypersil BDS C8 column, and the chromatographic separation was achieved with a mobile phase consisting of 50% buffer and 50% acetonitrile. Validation of the method was carried out following ICH guidelines, confirming its accuracy, precision, and robustness. The method demonstrated excellent linearity with correlation coefficients of 0.999 for both drugs and showed low limits of detection (LOD) and quantification (LOQ), indicating high sensitivity. Forced degradation studies, including oxidation, acid, alkali, and thermal degradation, were conducted to assess the stability of Sofosbuvir and Velpatasvir under different conditions, and the method proved to be robust and suitable for routine quality control applications in the pharmaceutical industry. The assay results for both drugs were within acceptable limits, ensuring the method's reliability for routine use in pharmaceutical quality testing.