UV-Spectrophotometric and Stability Indicating RP-HPLC Methods for the Determination of the Hepatitis C Virus Inhibitor Sofosbuvir in Tablet Dosage Form

Abstract

A UV-Spectrophotometric and Stability-indicating RP-HPLC methods are developed and validated for the determination of Sofosbuvir (SOF) in tablet dosage form. The RP-HPLC method is performed on the ACE C18 column (250 mm x 4.6 mm, 5 μm) particle size, using buffer solution of pH 5.0 containing 50 mM potassium dihydrogen phosphate: Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1.5 mL/min,injection volume 20 μL and UV detection at 260 nm. This method is validated according to ICH and USP requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, linearity and range. A linear range of 50-500 μg/mL with a correlation coefficient of 0.9996 and Rt value of 4.100 min for SOF. The forced degradation studies as acidity, alkalinity, oxidation, heat, thermal and photo degradation are performed according to ICH guidelines, therefore the method can be considered as a stability indicating one. The UV-spectrophotometric method is based on the measurement of the absorbance of SOF at λmax equals to 260 nm. A linear range of 5-50 μg/mL with a correlation coefficient of 0.9995, good accuracy and recovery for laboratory prepared mixture were achieved. The obtained results for the proposed methods are statistically compared with those obtained by the reported methods for SOF using student’s-t and F-ratio tests, showing that the proposed methods are accurate and precise.