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

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

  1. 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*

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

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