ISSN: 2249–9504
CAS CODEN: IJPCDX

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF GEFITINIB IN BULK AND ITS PHARMACEUTICAL FORMULATIONS

Abstract

Author(s): A. Sreedevi, A. Lakshmana Rao*and L. Kalyani

A simple, isocratic, accurate and precise stabilityindicating HPLC method has been developed and subsequently validated for the determination of Gefitinib in bulk and its pharmaceutical formulations. Separation was achieved on a Hypersil BDSC18column (100 mm x 4.6 mmI.D., 5 μm particle size) as stationary phase using a mobile phase consisting of phosphate buffer (pH 3.6)and acetonitrile (55:45v/v)at a flow rate of 1.0 mL/min and UV detection at 248 nm.The developed method is validated as per the ICH guidelines, which includes linearity, precision, accuracy, specificity, ruggedness and robustness. The current method demonstrates excellent linearity over the concentration range of 25-150 μg/mL for Gefitinib with correlation coefficient of 0.999.The mean recovery of the compound is 99.93%.The retention time was 4.179 min.The percentage assay of Gefitinib was 99.60%. The limit of detection and limit of quantification for Gefitinib was found to be 0.078μg/mL and 0.238μg/mL respectively. The drug Gefitinib was subjected to acidic, alkaline, oxidative, thermal, hydrolytic and photolytic stress conditions. The results showed that the proposed method is suitable for the determination of Gefitinib in bulk and pharmaceutical formulations.

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