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
2
,
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. 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.
