Wang Rong, Jia Zheng-Ping, Fan Jun-Jie, Ma Jun, Hua Xie, Zhang Qiang, Wang Juan
Department of Pharmacy, Lanzhou General Hospital, Lanzhou Command of PLA, Lanzhou 730050, China.
Pharmazie. 2009 Mar;64(3):156-60.
Cefotaxime enantiomers have specific effects on Gram-negative bacteria. For quality control of cefotaxime it was necessary to establish a method for enantioseparation by capillary zone electrophoresis (CZE) using cyclodextrin (CD) as a chiral selector. The effects of various parameters on enantioseparation were studied. A fused silica capillary (40 cm effective length x 75 microm ID) was used. The cefotaxime enantiomers were separated on the baseline under conditions of 0.5 mmol/L CM-beta-CD, 75 mmol/L NaH2PO4 buffer at pH 7.0 using UV detection at 280 nm. Applied voltage and capillary temperature were 20 kV and 25 degrees C, respectively. Under these conditions for enantioseparation, linear calibration curves were obtained in the range 2 approximately 160 microg/mL. The limit of detection for both isomers was less than 0.5 microg/mL. The method was used for analysis of pharmaceutical preparations (dosage forms) of cefotaxime from various factories. A simple and specific CZE method was successfully demonstrated for the separation of cefotaxime enantiomers. The enantioseparation method should be established and this method should be used to control the quality of cefotaxime.
头孢噻肟对映体对革兰氏阴性菌有特定作用。为了对头孢噻肟进行质量控制，有必要建立一种以环糊精（CD）作为手性选择剂，采用毛细管区带电泳（CZE）进行对映体分离的方法。研究了各种参数对对映体分离的影响。使用了一根熔融石英毛细管（有效长度40 cm×内径75μm）。在0.5 mmol/L CM-β-CD、pH 7.0的75 mmol/L NaH₂PO₄缓冲液条件下，于280 nm处采用紫外检测，头孢噻肟对映体实现了基线分离。施加电压和毛细管温度分别为20 kV和25℃。在这些对映体分离条件下，在2～160μg/mL范围内获得了线性校准曲线。两种异构体的检测限均小于0.5μg/mL。该方法用于分析来自不同厂家的头孢噻肟药物制剂（剂型）。成功证明了一种简单且特异的CZE方法可用于头孢噻肟对映体的分离。应建立对映体分离方法，并将该方法用于控制头孢噻肟的质量。
