Analytical Method Development and Validation of RP-HPLC Method for the Determination of Gemcitabine in Bulk and Pharmaceutical Dosage Forms

ABSTRACT A rapid and sensitive high performance liquid chromatographic method was developed for the estimation of Gemcitabine in bulk and pharmaceutical dosage forms. Gemcitabine was chromatographed on a Zorbax R X C 8 , (250mm× 4.6mm, 5µ) using a mobile phase consisting of phosphate buffer (pH 3.0) and methanol in the ratio of 85:15 v/v. The flow rate was maintained at 1.2 ml/min and eluents were detected at 275 nm. The retention time of Gemcitabine was found to be 11.78 min. The proposed method was validated by determining accuracy, precision, specificity and system suitability parameters. Linearity was observed in the range of 25-150 µg/ml. The mean recovery of 100.0±0.32 of the drug was indicating high level of accuracy of the method. Due to its simplicity, accuracy and high precision the proposed HPLC method was found to be appropriate for the estimation of Gemcitabine in bulk and pharmaceutical dosage forms