Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SOFOSBUVIR IN PURE AND PHARMACEUTICAL FORMULATION

Shaadmin N. Shaikh* and Manjushri P. Dabhade

ABSTRACT

A simple and precise method was developed for the assay of Sofosbuvir from tablet formulation. The several spectrophotometric and HPLC methods have been reported for determination of Sofosbuvir individually or in combination with other drugs in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, suitable and cost effective reversed-phase high performance liquid chromatographic method was developed and validated for the determination of Sofosbuvir in bulk and pharmaceutical formulation. In RP-HPLC method, the analyte were resolved by using isocratic program, Methanol and Phosphate buffer (45:55 v/v) pH-3 was used as mobile phase, at a flow rate of 0.9ml/min, on HPLC system containing UV- visible detector with Workstation Software and Greece C18 column (4.6 x 250 mm; 5μm). The detection was carried out at 261nm. The method gave the good resolution and suitable retention time. The results of analysis in the method were validated in terms of accuracy, precision, specificity, linearity, limit of detection, limit of quantification and robustness. The method does not require use of expensive reagent and also less time consuming, it can be performed routinely in industry for routine analysis of marketed product of Sofosbuvir.

Keywords: RP-HPLC, Sofosbuvir, Methanol, Phosphate Buffer.