The proposed work was accurate and precise stability indicating RP-HPLC method has been developed and validation of Sofosbuvir, in tablet dosage form. The separation was achieved on a Kromasil C18 (4.6×250 mm, 5µ) column using a mixture of Methanol: water (60: 40% v/v) as the mobile phase at a flow rate of 1.0 mL/min and detected 247 nm. The retention time of sofosbuvir 3.475 minutes. The linear responses in the concentration range of 10-60 µg/mL of Sofosbuvir. The method precision for the determination of assay was less than 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Sofosbuvir; RP-HPLC; Validation; Tablet dosage forms.