Simultaneous Determination of Three Impurities in Caspofungin Acetate by LC-MS
10.13748/j.cnki.issn1007-7693.20231194
- VernacularTitle:LC-MS同时测定醋酸卡泊芬净中的3种杂质
- Author:
Yongjun ZHANG
1
;
Ziqi LIANG
2
;
YONGzheng GUO
1
;
Yonghua ZHU
1
;
Wenwu ZHOU
1
;
Shufang WANG
3
Author Information
1. Zhejiang Wild Wind Pharmaceutical Co., Ltd., Dongyang 322100, China;
2. Innovation Center of Translational Pharmacy, Jinhua Institute of Zhejiang University, Jinhua 321016, China;
3. Innovation Center of Translational Pharmacy, Jinhua Institute of Zhejiang University, Jinhua 321016, China; College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China
- Publication Type:Journal Article
- Keywords:
caspofungin acetate , impurity , LC-MS
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(24):3418-3422
- CountryChina
- 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.
