Analytical Validation and Development of Cefixime Drug Substances in Pharmaceutical Formulations by Gas Chromatography

Abstract

The present study was conducted to develop and validate an analytical procedure for the determination of cefixime in Pharmaceutical Formulations. The analytical test attributes and evaluated as per the guidelines of ICH Q2 (R1). The method was validated for the determination of Assay in finished products of cefixime and the method validation parameters were evaluated for the analytical test attribute cefixime meets the acceptance criteria. The results obtained were within the specified limits and the samples were analyzed for test item concentration by Chromatography.