METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF GEMCITABINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2011, Vol 1, Issue 5
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.
Authors and Affiliations
R. MURALI KRISHNA, M. RAMESH, T. SIVA KUMAR
Keywords
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