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A reversed-phase selective and sensitive liquid chromatography coupled with tandem mass spectrometric (LC-MS/MS) method was developed and validated for the trace analysis of (0.5 ppm level) of 4-(bromomehtyl)benzoic acid genotoxic impurity in imatinib mesylate drug substance. The method obtained with Inertsil C18 column (250 mm×4.6 mm, 5.0 μm) with negative electrospray ionization in multiple reaction monitoring (MRM) detection mode.Mobile phase was 0.1% formic acid in water and acetonitrile in the ratio of 35:65(v/v). Isocratic program was developed and the flow rate was 1.0 mL/min and elution was monitored by mass spectrophotometer. The method was validated as per International Conference on Harmonization (ICH) guidelines and was able to quantitate up to 0.5ppm of 4-bromo mehtyl benzoic acid.

international journal of science and research

Development of an LC-MS/MS Method for Trace Level Quantification of 4-(bromomethyl) Benzoic Acid, a Potential Genotoxic Impurity in Imatinib Mesylate Drug Substance