RP-HPLC Analysis of Gemcitabine in Pure Form and in Pharmaceutical Dosage Forms

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the estimation of gemcitabine in pure form as well as in its tablet dosage forms. The quantification was carried out using an ODS column (250 × 4.6 mm ID), 5 μ particle size with a mobile phase comprising of water and acetonitrile in the ratio 30:70 (v/v) in isocratic mode at a flow rate of 1.0 mL/min. The eluent was monitored at 234 nm. The retention time was 2.20 min. Racecadotril was used as an internal standard. The method was duly validated by evaluation of the required parameters. The calibration curve was linear in the concentration range of 1-300 μg/mL and the percentage recovery ranged from 99.98-100.30.