Ведомости Научного центра экспертизы средств медицинского применения (Feb 2018)
Column chromatography USED in purification of genotoxic impurity sample of imatinib mesylate substance
Abstract
The article describes a simple method for purifying N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine for further use as a standard for quantitative determination of genotoxic impurities substance imatinib mesylate. Experimentally proved choice of sorbent used for purification of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine. The advantage of column chromatography on neutral alumina prior to crystallization methods presented in the literature. Comparative chromatographic and spectral characteristics of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine before and after purification. NMR spectroscopy evaluated quantitative content of the target substance in the purified sample.