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Nonaqueous capillary electrophoresis of imatinib mesylate and related substances
Author(s) -
Ye Lei,
Huang Yifei,
Li Jian,
Xiang Guangya,
Xu Li
Publication year - 2012
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.201200114
Subject(s) - chromatography , methanesulfonic acid , chemistry , benzamide , analyte , imatinib mesylate , capillary electrophoresis , mesylate , electrolyte , stacking , methanol , analytical chemistry (journal) , stereochemistry , electrode , organic chemistry , imatinib , myeloid leukemia , immunology , biology
In the present study, nonaqueous capillary electrophoretic separation of imatinib mesylate ( IM ) and related substances, N ‐(5‐amino‐2‐methylphenyl)‐4‐(3‐pyridyl)‐2‐pyrimidinamine ( PYA ), N ‐(4‐methyl‐3‐(4‐(pyridin‐3‐yl)pyrimidin‐2‐ylamino)phenyl)‐4‐((piperazin‐1‐yl)methyl) benzamide ( NDI ) and 4‐chloromethyl‐ N ‐(4‐methyl‐3‐((4‐(pyridin‐3‐yl) pyrimidin‐2‐yl) amino) phenyl) benzamide ( CPB ) was developed. The influential factors affecting separation, including type and concentration of the electrolyte, applied voltage, and buffer modifier were investigated. Baseline separation of the studied analytes was obtained using a buffer of 50 mM T ris and 50 m M methanesulfonic acid in methanol at a apparent p H (p H *) of 1.65. To enhance the sensitivity, large‐volume sample stacking was employed for online concentration. The strongest analytical signal with a suitable separation was achieved when the injection time was 100 s. The linearity ranges of PYA and NDI were 0.100–2.50 μg mL −1 , and that of CPB was 0.125–2.50 μg mL −1 , with good coefficients ( r 2 > 0.9948). The relative standard deviations of intra‐ and interday were satisfactory. Under the optimized conditions, seven batches of the synthesized samples were analyzed and CPB was detected in two batches. Owing to its simplicity, effectiveness, and low price, the developed method is promising for quality control of IM .