Analysis of Related Substances in Biapenam by Micellar Electrokinetic Capillary Chromatography
ZHANG Han-zhi1, LI Min2, LUO Wen-yan1, DING Ying1, LIU Hao1*
1. Shanghai Institute for Food and Drug Control, Shanghai 201203, China; 2. Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Abstract：OBJECTIVE To establish a method for analysis of related substances in biapenem with micellar electrokinetic capillary chromatography(MEKC). METHODS In order to improve the separation selectivity, a zwitterionic surfactant, 3-(N,N-dimethylhexadecylammonium)-propanesulfonate(PAPS) was used. The optimal separation conditions were as follows: the total length of the capillary was 48.5 cm (the effective length was 48 cm), the buffer was 90 mmol·L-1 tris(hydroxymethyl)aminomethane (tris)-phosphate buffer containing 17 mmol·L-1 PAPS and 3 mg·mL-1 polyoxyethylene 23 lauryl ether (Brij 35), the applied voltage was 22 kV, and the capillary temperature was controlled at 30 ℃. Further more,the specificity, linearity, precision, repeatability, stability and durability were studied. The contents of related substances in biapenem commercial samples were analyzed. RESULTS The MEKC method, which was a comparable analysis method to HPLC, successfully separated the adjacent impurities of biapenem by using the zwitterionic surfactant PAPS. The specific test showed that this method was especially suitable for the detection of biapenem dimers A, B and open-ring compound. CONCLUSION In this method, MEKC with zwitterionic surfactant is for the first time applied to the analysis of related substances in biapenem (amphoteric drugs). It provides a feasible analysis method with high sensitivity, good specificity and reproducibility for the quality control of biapenem.
张含智,李敏, 罗文燕, 丁颖, 刘浩. 胶束电动毛细管电泳法分析比阿培南中的有关物质[J]. 中国药学杂志, 2020, 55(16): 1367-1371.
ZHANG Han-zhi, LI Min, LUO Wen-yan, DING Ying, LIU Hao. Analysis of Related Substances in Biapenam by Micellar Electrokinetic Capillary Chromatography. Chinese Pharmaceutical Journal, 2020, 55(16): 1367-1371.
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2020, Vol. 55 
