Chinese Journal of Modern Applied Pharmacy 2023;40(24):3418-3422

doi: 10.13748/j.cnki.issn1007-7693.20231194

Simultaneous Determination of Three Impurities in Caspofungin Acetate by LC-MS

Yongjun ZHANG 1 ; Ziqi LIANG 2 ; YONGzheng GUO 1 ; Yonghua ZHU 1 ; Wenwu ZHOU 1 ; Shufang WANG 3

Affiliations

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Keywords

caspofungin acetate , impurity , LC-MS

Country

China

Language

Chinese

Abstract

Abstract: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 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.