Determination of Three Potential Genotoxic Impurities in Imatinib Mesylate by Gas Chromatography-Mass Spectrometry

摘要

Two sensitive methods are reported for the determination of potential genotoxic impurities in imatinib mesylate by gas chromatography-mass spectrometry. The methods were used for the determination of hydrazine, 3-acetylpyridine, and 2-methyl-5-nitroaniline in imatinib mesylate. Hydrazine was quantified following its conversion into a volatile derivative with n-hexadecane as the internal standard. 3-Acetylpyridine and 2-methyl-5-nitroaniline were determined at low ppm levels using 1-eicosanol as the internal standard. Liquid extraction procedures were used for sample preparation. Mass spectrometry detection provided good sensitivity and specificity using selected ion-monitoring mode. The limits of detection for hydrazine, 3-acetylpyridine, and 2-methyl-5-nitroaniline were 0.11, 0.026, and 0.025 mu g g(-1), respectively. The developed methods provided suitable figures of merit for the analysis of imatinib mesylate.