Forced Degradation Studies of Sofosbuvir with a Developed and Validated RP-HPLC Method as per ICH Guidelines

A reverse phase-high-performance liquid chromatography-diode array detector method is developed for the determination of the antiviral drug sofosbuvir in bulk and Sofos ® 400 mg tablet dosage forms. Sofosbuvir is used for the treatment of chronic hepatitis C. The separation is carried out using a gradient mobile phase consisting of 0.05% H 3 PO 4 and acetonitrile. A symmetry C 18 column (4.6 × 100 mm, 2.5 µm, Waters XSELECT HSS T3) is used with a flow rate of 1.5 mL min −1 using ultraviolet detection at 260 nm with a diode array detector and an injection loop volume of 10 µL. A sharp peak is obtained at a retention time of 14 min. The method is validated appropriately according to the requirements of the United States Pharmacopeia and the International Conference on Harmonization guideline Q2 R1. System suitability, linearity, range (1.5–4.5 µg mL −1 ), precision, accuracy, specificity, robustness, detection and quantification limit of the method are assured. A forced degradation study of sofosbuvir is conducted under the conditions of hydrolysis, oxidation, thermal and photolysis.