Volume :
3
Issue :
1
Abstract :
A simple, precise and accurate stability indicating RP-HPLC method has been developed and subsequently validated for estimation of Sofosbuvir (SOF) n bulk and from their combination dosage form using a Kromasil C18 (250mm × 4.6 mm, 5µ) at 250C. Mobile phase consisted mixture of 0.1% Ortho phosphoric acid buffer and acetonitrile in the ratio 55:45 (v/v) with flow rate was 1 ml/min and detection was carried out by photodiode array detector at 260nm. The retention time for SOF was found to be 2.06 min. SOF and their dosage form were exposed to thermal, photolytic, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed by proposed method. Peak purity results suggested no other co-eluting, interfering peaks from excipients, impurities, or degradation products due to variable stress condition, and the method is specific for the estimation of SOF in presence of their degradation products and impurities. The proposed method has permitted the quantification of SOF over linearity in the range of 100 – 600 µg/ml and its percentage recovery was found to be 99.10 – 101.74 %. The % RSD of intraday and inter day precision were found 0.3% and 0.6% according to International Conference on Harmonization (ICH) Q2B guidelines.