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Development of a high sensitivity RP-HPLC method and stress testing of imatinib mesylate


Lalit Mohan Negi , Manu Jaggi , Sushama Talegaonkar

Abstract

The present investigation was aimed to establish a simple, accurate and highly sensitive validated stability-indicating liquid chromatographic method for imatinib mesylate. The purpose was to develop a method to detect nanogram quantity of the drug specific in development of nanoparticles. Imatinib mesylate was successfully analysed in a broad range from 50 to 50,000 ng/ml on Develosil® ODS-HG-5, Nomula chemical (50 mm×4.6 mm) analytical column, using 55:45 (v/v) aqueous (pH 8) to organic phase ratio (methanol and acetonitrile, 6:4) as the mobile phase, at a flow rate of 1.0 mL/min and detection at 267 nm with a good linearity (R2 > 0.9992). The method was validated for precision, accuracy, robustness, sensitivity and specificity. The method was further utilized to evaluate the fate of imatinib mesylate under various stress conditions including acid, alkaline, oxidation and photo degradation. The method was highly specific to determine pure drug from the degraded products. Further, it was inferred by the results that imatinib is less labile to alkaline and photo degradation.



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