High-sensitivity analysis method for gene impurity of imatinib

2016 
The invention relates to a high-sensitivity analysis method for a gene impurity of imatini. The analysis method is developed for the gene impurity F of imatinib, the high performance liquid chromatography-mass spectrometry is adopted, a mixed phase of an organic solvent and water is used to dissolve a sample and gradient elution is performed on a chromatographic column of octadecyl bonded silica by taking acetonitrile and ammonium formate of which the pH is 3.5 as mobile phases. The method disclosed by the invention simply and effectively solves the problems of low sensitivity and weak specificity in detection of the impurity F, and more efficiently separates and detects the gene impurity F of imatinib.
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