Simultaneous Determination of Three Impurities in Caspofungin Acetate by LC-MS
OBJECTIVE To develop LC-MS method for the simultaneous determination of impurities A,C,and D of caspofungin acetate.METHODS Waters CORTECS® C18+(4.6 mm× 150 mm,2.7 μm)was used as the chromatography column.Mobile phase A and B were 0.1％formic acid-H2O and 0.1％formic acid-CH3CN,respectively.Electrospray ion source-single quadrupole mass spectrometry was used to detect impurities A and C in positive ion mode and impurity D in negative ion mode.RESULTS The correlation coefficient r was ≥0.999 3 in linearity ranges of impurities A,C and D.The average recoveries were 100.5％,104.1％and 105.2％,respectively,with RSD＜4％(n=6).The LOQs(S/N=10)of impurities A,C and D were 31.8,6.99 and 15.5 ng·mL 1 respectively.The contents of impurities A,C and D in the three samples were all below the limits.CONCLUSION The developed LC-MS method is simple,sensitive,and applicable,which can be used to simultaneously determine impurities A,C and D in caspofungin acetate and can also provide a reference for the detection of other impurities in caspofungin acetate.
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万方数据
维普
