| 刊名 | Medicinal Plant |
| 作者 | Shiqiang OU， Yanxi LAI， Peng XIE， Hao LIU， Shicheng LIU， Jin QIN， Yiping QIN， Yizhang WANG， Shengjiu GU |
| 作者单位 | Guangxi Kelun Pharmaceutical Co., Ltd.； College of Pharmacy, Guilin Medical University |
| DOI | 10.19601/j.cnki.issn2152-3924.2024.05.006 |
| 年份 | 2024 |
| 刊期 | 5 |
| 页码 | 22-26，30 |
| 关键词 | Cefathiamidine, Cephalosporin polymer impurities, Impurity analysis, High Performance Liquid Chromatography-Mass Spectrometry |
| 摘要 | [Objectives] To establish a HPLC-MS method for the determination of polymer impurities in cefathiamidine and its preparations. [Methods] Kromasil 100-5 C18 column (4.6 mm×250 mm, 5 μm) was used for analysis; mobile phase ammonium acetate solution (pH 6.30)-acetonitrile, gradient elution; volumetric flow rate 1.0 mL/min; column temperature 40 ℃; multi-reaction monitoring mode was used for analysis, and positive ion scanning was chosen as the electrospray ion source. [Results] The resolution between impurities and main peaks under this method was greater than 1.5, and 8 known impurities and 2 polymer impurities could be completely separated and distinguished. It was inferred that the molecular ion peak [M+H]+: m/z 727.187 4,m/z 785.193 7 was the possible polymer impurity of this product. [Conclusions] A method for the analysis of polymer impurities in cefathiamidine and its preparations was formed, which could achieve the purpose of simultaneous analysis of small molecule impurities and polymer impurities, and could better control the content of single impurities in the polymer, providing a reliable inspection basis for strict control of cefathiamidine quality. |
