毛细管电泳分析β-内酰胺抗生素杂质最佳分离模式的选择

毛细管电泳分析β-内酰胺抗生素杂质最佳分离模式的选择

朱健萍, 张慧文, 胡昌勤^*

1. 中国药品生物制品检定所, 北京 100050
2. 广西壮族自治区药品检验所, 广西南宁 530021
3. 广州市药品检验所, 广东广州 510160

收稿日期:2010-01-31 修回日期:2010-06-10 出版日期:2010-07-15 发布日期:2010-07-15
通讯作者: 胡昌勤*

Optimal mode of capillary electrophoresis for the impurity analysis of β-lactam antibiotics

Jian-Ping Zhu, Hui-Wen Zhang, Chang-Qin Hu^*

1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
2. Guangxi Institute for Drug Control, Nanning 530021, China
3. Guangzhou Institute for Drug Control, Guangzhou 510160, China

Received:2010-01-31 Revised:2010-06-10 Online:2010-07-15 Published:2010-07-15
Contact: Chang-Qin Hu*

摘要/Abstract

摘要：

采用β-内酰胺模型化合物, 以不同毛细管电泳分离条件对β-内酰胺抗生素中常见的同分异构体及其杂质的分离能力为指标, 证明MEKC是β-内酰胺抗生素杂质谱分析的最佳分离模式, 不仅可以有效地分离β-内酰胺抗生素中常见的R、S-异构体, Δ-2、Δ-3-异构体、和Z、E-顺反异构体, 且较CEZ模式可以分离出更多的杂质, 因此MEKC模式是毛细管电泳分离β-内酰胺抗生素杂质的首选分离模式。通过对运行缓冲液pH、缓冲盐浓度、胶束浓度和有机改性剂(甲醇)浓度的进一步优化, 可以实现MEKC模式的最佳分离。

关键词: β-内酰胺抗生素, 杂质, 毛细管区带电泳, 胶束电动毛细管色谱, 最佳分离模式

Abstract: In order to determine the optimal mode of capillary electrophoresis for the impurity control of β-lactam antibiotics, different modes and various electrophoresis conditions for the separation of impurities were compared. The results showed that micellar electrokinetic capillary chromatography (MEKC) was the optimal separation mode for the impurity profiling of β-lactam antibiotics. In MEKC, not only the common R and S isomers, Δ-2 and Δ-3 isomers, and Z and E isomers, but also the impurities of β-lactam antibiotics could be well separated compared with the capillary zone electrophoresis. Therefore, MECK is the first choice for the separation of impurities of β-lactam antibiotics with capillary electrophoresis (CE). The optimal separation could be achieved in MEKC by optimizing the pH and the concentrations of buffered saline, micelles and organic solvent (methanol) in running buffer.

Key words: β-Lactam antibiotics, Impurity, CZE, MEKC, Optimal separation mode

中图分类号:

R917.795

Supporting: Foundation item: National Key New Drug R & D Program Foundation of China (Grant No. 2009ZX09313-027).
^*Corresponding author. Tel.: 86-10-67095308

朱健萍, 张慧文, 胡昌勤^*. 毛细管电泳分析β-内酰胺抗生素杂质最佳分离模式的选择[J]. .

Jian-Ping Zhu, Hui-Wen Zhang, Chang-Qin Hu^*. Optimal mode of capillary electrophoresis for the impurity analysis of β-lactam antibiotics [J]. .

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