Abstract

A simple and precise, rapid and accurate RP-HPLC method has been
developed and validated for the determination of gemcitabine hydrochloride in
pharmaceutical dosage forms. The chromatographic separation was achieved
on kromasil stainless column (150 X 4.6 mm, 5.0 μ particle size) using
acetonitrile : water (40 : 60), flow rate 1.0 mL/min. The analyte was
monitored using UV-Visible detector at 270 nm. The retention time of the
drug was 4.093 min for gemcitabine hydrochloride. The proposed method
was found to have linearity in the concentration range 80-120 μg/mL with
correlation coefficient of r2 = 0.999. The method was validated for linearity,
precision, LOD, LOQ and robustness. The proposed method was optimized
and validated as per the ICH guidelines.