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Abstract

A Simple, accurate and rapid RP-HPLC method has been developed for the estimation of Sofosbuvir (SOF) in bulk and pharmaceutical dosage forms using a Kromasil C18 (250mm × 4.6 mm, 5µm) with mobile phase comprising 0.1% Ortho phosphoric acid buffer and acetonitrile in the ratio 55:45 (v/v).The flow rate was 1 ml/min and detection was carried out by photodiode array detector at 259nm. The retention time for SOF was found to be 2.069 min. the proposed method has permitted the quantification of SFB over linearity in the range of 0.10 – 0.60 mg/ml and its percentage recovery was found to be 100.39 %. The % RSD of intraday and inter day precision were found 0.34% and 0.60% according to International Conference on Harmonization (ICH) Q2B guidelines.

Keywords

Sofosbuvir RP-HPLC Validation and method development

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