METHOD DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR ASSAY DETERMINATION OF IMATINIB IN IMATINIB MESYLATE TABLETS DOSAGE FORM

A simple, rapid and isocratic reversed phase high performance liquid chromatographic (RP-HPLC) stability indicating method was developed and validated for the determination of Imatinib in tablet dosage form. Imatinib drug was exposed to several stress conditions. The proposed method proved to be stability indicating by forced degradation experiments and mass balance study. The chromatographic separation was achieved using Eclipse XDB-C18 (150 mm X 4.6 mm) 5µ analytical column as the stationary phase with isocratic elution of the mobile phase composition of 1.5 g of Sodium dihydrogen phosphate in to 500 ml of water and adjust pH 8.00 with Triethylamine (buffer preparation) : pepared a mixture of 300 ml volumes of methanol and 200 ml volumes of acetonitrile (solvent mixture) mixed in a proportion of 450:550v/v at a flow rate of 1.0 ml/minute. The column oven temperature was maintained at 50°C. The Sample temperature was maintained at room temperature. The injection volume was set to 20 µl and the detector was performed at 265 nm. The retention time of the Imatinib was found to be about 5.5 minute. The linearity concentration range was 19.815-29.722 µg/ml with correlation coefficients 0.99990. The developed method was validated in accordance with ICH guidelines