Analysis of polymer impurities in cefixime raw materials and preparations
10.16438/j.0513-4870.2020-0643
- VernacularTitle:头孢克肟原料及制剂的聚合物杂质分析
- Author:
Jin LI
1
;
Shang-chen YAO
1
;
Li-hui YIN
1
;
Ming-zhe XU
1
;
Chang-qin HU
1
Author Information
1. National Institutes for Food and Drug Control, Beijng 102629, China
- Publication Type:Research Article
- Keywords:
cefixime;
polymer;
impurity;
column-switching LC-MSn;
high performance size exclusion chromatography;
italic>β-lactam antibiotics
- From:
Acta Pharmaceutica Sinica
2020;55(10):2442-2448
- CountryChina
- Language:Chinese
-
Abstract:
To establish a method for the determination of polymer impurities in cefixime raw materials and preparations, a cefixime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSn method. A new RP-HPLC method for cefixime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.5% formic acid-water solution and 0.5% formic acid-acetonitrile solution. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, three polymer impurities were detected with good specificity, sensitivity and robustness, including two cefixime dimers, and dehydrate dimer. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in cefixime, and cefixime degradation solution can be used as suitable solution for analysis of cefixime polymers.
