Research on polymer impurities in cefazolin sodium raw materials and products
10.16438/j.0513-4870.2020-1601
- VernacularTitle:头孢唑林钠原料及制剂中的聚合物杂质研究
- Author:
Xia ZHANG
;
Jin LI
;
Chen WANG
;
Ying LIU
;
Shang-chen YAO
;
Li-hui YIN
;
Ming-zhe XU
;
Chang-qin HU
- Publication Type:Research Article
- Keywords:
polymer impurity;
cefazolin sodium;
column switching liquid chromatography-high resolution mass spectrometry;
two-dimensional liquid chromatography;
sephadex gel chromatography;
high-performance gel chromatography
- From:
Acta Pharmaceutica Sinica
2021;56(6):1677-1682
- CountryChina
- Language:Chinese
-
Abstract:
Research on polymer impurities has always been important in the quality control of cephalosporins. Research on polymers in cephalosporins that lack active amino groups on the C-7 side chain has not been reported. Therefore, our study used cefazolin sodium, which is widely used in the clinic, as an example. The polymer in cefazolin sodium and its product "cefazolin sodium pentahydrate for injection" was analyzed by column switching liquid chromatography-high resolution mass spectrometry. Two polymer impurity peaks were detected and the possible structures of these polymers were suggested. Through two-dimensional liquid chromatography, the chromatographic peaks following Sephadex gel chromatography and high-performance gel chromatography were compared to those obtained by reverse high-performance liquid chromatography (HPLC) for cefazolin sodium as reported in the Chinese Pharmacopoeia. The HPLC method proves more suitable for polymer detection than Sephadex gel chromatography and high-performance gel chromatography. The method of polymer detection for cefazolin sodium was established using the method of related substances HPLC as described in the Chinese Pharmacopoeia.
