Development of Analytical Method by RP-HPLC Technique for Determination of Imatinib mesylate in Bulk Drug and Pharmaceutical Dosage Form

A novelreverse phase liquid chromatographic methodwas developed and validated for estimation of chronic myelogenous leukemia and acute lymphocytic leukemia drug, imatinib mesylate in its API and dosage form i.e. tablets. The reverse phase HPLC analysis was carried out on isocratic system. The column was Peerless basic C18 (50mm x 4.6mm, 3μm) with ambient temperature. The mobile phase consisted of buffer: methanol in proportion 45: 55% (v/v). The flow rate was maintained at 1ml/min. The detection was carried out at wavelength 266 nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy and precision. The linear ranges was observed as 50–150μg/mlforimatinibmesylate. The accuracy and precision were found to be well within the acceptable limit. The method was successfully applied for assay imatinib mesylate of in API and dosage form with good recoveries.