Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF SOFOSBUVIR BY PURE AND TABLET DOSAGE FORM”

Jayesh A. Patil*, S. T. Patil, B. R. Rane and S. P. Pawar

Abstract

A simple, precise, rapid and reproducible RP-HPLC method was developed and validated for the determination of Sofosbuvir in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a C18 (PRIMESIL) column (250 X 4.6 mm i.d., particle size 5μm.). The mobile phase consisted of Acetonitrile:Water (pH 2.4 adjusted with 0.05% orthophosphoric acid) in ratio 80:20 (v/v) an gradient elution at a flow rate of 0.7 ml/min at ambient temperature. The detection was carried out at 260nm using UV-Visible detector. The retention time of Sofosbuvir is found to be 4.3 min and the calibration curve was linear in the concentration range of 20-100 μg/ ml (r2═ 0.997). The limit of detection and the limit of quantification were found to be 0.5355 and 1.6228 μg/ml respectively. The amount of sofosbuvir present in the formulation was found to be 99%. The method was validated statistically using the SD, %RSD and values are found to be within the limits and the recovery studies were performed and the percentage recoveries was found to be 98% (±1%) to 102%(±1%). So, the proposed method was found to be simple, specific & linear. Hence it can be applied for routine analysis of sofosbuvir in the pharmaceutical formulations.

Keywords: RP-HPLC, Sofosbuvir, UV detection, Acetonitrile:water.