Analysis of polymer impurities in ceftazidime raw materials and preparations
10.16438/j.0513-4870.2020-0084
- VernacularTitle:头孢他啶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:
ceftazidime;
polymer;
impurity;
column-switch LC-MSn;
high performance size exclusion chromatography;
italic>β-lactam antibiotics
- From:
Acta Pharmaceutica Sinica
2020;55(8):1889-1896
- CountryChina
- Language:Chinese
-
Abstract:
To establish a method for the determination of polymer impurities in ceftazidime raw materials and preparations, a ceftazidime 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 ceftazidime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.02 mol·L-1 phosphate buffer, methanol and acetonitrile. 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, four polymer impurities were detected in the 25-45 min time range with good specificity, sensitivity and robustness, including two ceftazidime dimers, trimers, and derivatives. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in ceftazidime, and ceftazidime degradation solution can be used as suitable solution for analysis of ceftazidime polymers.
