高效分子排阻色谱法测定头孢呋辛酯片中的高分子量杂质  

Determination of the high molecular weight related substance in cefuroxime axetil tablets by high performance size exclusion chromatography

作　　者：张雷[1] 董红环[1] 刘洋[1] 朱寅荻[1] 程显隆[2] 徐暾海[1] 吕贝然[1] 

机构地区：[1]北京中医药大学,北京100102 [2]中国食品药品检定研究院,北京100050

出　　处：《中国抗生素杂志》2015年第12期922-924,929,共4页Chinese Journal of Antibiotics

摘　　要：目的建立头孢呋辛酯片高分子量杂质的检查方法。方法采用TSK-GEL G2000HHR色谱柱(7.8mm×300mm,5μm),流动相为含30mmol/L溴化锂的N,N-二甲基甲酰胺溶液,流速0.33m L/min,检测波长278nm。结果对该分析方法的专属性、精密度、线性与范围、灵敏度、重复性等进行考查,各项指标均良好;3批头孢呋辛酯片样品高分子量杂质的含量分别为0.45%、0.41%和0.45%。结论该法简便、准确、专属性高,可用于头孢呋辛酯片中高分子量杂质的检查。Objective To establish a method to determine the high molecular weight related substance in cefuroxime axetil tablets. Methods The high performance size exclusion chromatography system consisted of TSK-GEL G2000HHR chromatographic column （7.8mm×300mm, 5μm）, ultraviolet detector at 278nm wavelength and 30mmol/L lithium bromide N,N-dimethyl formamide solution as the mobile phase. Results The determination method of HPLC was reliable. The study of system suitability, specificity, precision, linearity and range, limit of detection and limit of quantitation and reproducibility of this analysis method were carried out. As a result, all the indicators were good. The content of the high molecular weight related substance in three batches of cefuroxime axetil tablets were 0.45%, 0.41%, and 0.45%. Conclusion The high performance size exclusion chromatography method is sensitive, accurate and fast. It can be used to determination the high molecular weight related substance content in cefuroxime axetil tablets.

关 键 词：头孢呋辛酯片 高效分子排阻色谱法 高分子量杂质 

分 类 号：R978.11[医药卫生—药品]