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E-Journal of Chemistry
Volume 7 (2010), S1, Pages S239-S244
http://dx.doi.org/10.1155/2010/724915

A Stability Indicating RP-HPLC Method for the Estimation of Gemcitabine HCl in Injectable Dosage forms

Shaik Mastanamma, G. Ramkumar, D. Anantha Kumar, and J. V. L. N. Seshagiri Rao

Pharmaceutical Analysis and Quality Assurance Division, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530 003, India

Received 12 April 2010; Accepted 5 June 2010

Copyright © 2010 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A stability indicating RP HPLC method has been developed for the determination of gemcitabine hydrochloride. Chromatography was carried out on an ODS C18 column (250×4.6 mm; 5μ) using a mixture of methanol and phosphate buffer (40: 60 v/v ) as the mobile phase at a flow rate of 1.0 mL/min. The detection of the drug was monitored at 270 nm. The retention time of the drug was found to be 2.31 min. The method produced linear responses in the concentration range of 10 to 60 μg/mL of gemcitabine HCl. The method was found to be reproducible for analysis of the drug in injectable dosage forms. The stability of the drug was assessed by forced degradation studies.