Development and Validation of RP-HPLC Method for the Determination of Gemcitabne Hydrochloride in Bulk and Parentral Dosage Form

Abstract

Author(s): Shilpa P, YR Anitha, Vasanth PM, Ramesh M, Ramesh T

A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Gemcitabine hydrochloride in bulk and parentral dosage form. The chromatographic method was standardized using ODS column with PDA detection at 285 nm and mobile phase consisting of ammonium acetate (0.025M): methanol (40:60 v/v) at a flow rate of 1.0 mL/min. The proposed method was successfully applied to the determination of Gemcitabine hydrochloride in bulk and parentral dosage form. The method was linear over the range of 5 – 40μg/mL. The recovery was in the range of 98.17 to 100. 40% and limit of quantification was found to be 0.16μg/mL. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) Q2Bguide