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1. (WO2017152689) HIGH-SENSITIVITY ANALYSIS METHOD FOR IMATINIB GENOTOXIC IMPURITIES

Pub. No.:    WO/2017/152689    International Application No.:    PCT/CN2016/111651
Publication Date: Fri Sep 15 01:59:59 CEST 2017 International Filing Date: Sat Dec 24 00:59:59 CET 2016
IPC: G01N 30/88
G01N 30/34
Applicants: JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD.
江苏豪森药业集团有限公司
Inventors: ZHANG, Cui
张翠
LIU, Jian
刘建
DU, Zuyin
杜祖银
Title: HIGH-SENSITIVITY ANALYSIS METHOD FOR IMATINIB GENOTOXIC IMPURITIES
Abstract:
A high-sensitivity analysis method for imatinib genotoxic impurities. For imatinib genotoxic impurity F, an analysis method has been developed which uses a combination of high performance liquid chromatography-mass spectrometry, using mixed-phase organic solvent and water to dissolve a sample, the mobile phase being acetonitrile and ammonium formate at pH=3.5, and gradient elution being performed in an octadecyl bonded silica gel chromatographic column. The present method simply and effectively solves the problems of low sensitivity and weak specificity in detection of impurity F, and more effectively separates and detects imatinib genotoxic impurity F.