HPLC-柱切换法归属青霉素钠有关物质中的聚合物分析  

Analysis of polymer impurities in related substances of benzylpenicillin sodium by HPLC-column-switching

作　　者：杨美琴[1] 金少鸿[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第10期1615-1620,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:在缺少杂质β-内酰胺抗生素聚合物对照品的条件下,定位青霉素钠在RP-HPLC系统中的聚合物色谱峰,进而实现β-内酰胺抗生素凝胶色谱系统(GFC)聚合物分析与RP-HPLC系统有关物质分析方法的统一。方法:采用6.0版欧洲药典青霉素钠的HPLC分析方法,利用各种专属性加速试验结合紫外特征吸收光谱及柱切换技术,在HPLC色谱图中定位各类青霉素杂质。结果:杂质p可以作为表征青霉素聚合物的指针性杂质,实现凝胶色谱系统和RP-HPLC的统一。结论:丰富了β-内酰胺抗生素聚合物分析方法,为实现对β-内酰胺抗生素聚合物杂质的有效控制提供了新思路。Objective：To identify the polymer impurities in RP - HPLC chromatogram of benzylpenicillin sodium without any references, thus to realize theβ- lactam antibiotics analysis unification between the polymer impurity （ gel filtration chromatography, GFC ） and the related substances （ RP - HPLC ）. Methods： The 6. 0 edition of European Pharmacopoeia HPLC method of benzylpenicillin sodium has been adopted. This issue also employs kinds of selectivity accelerated experiments, UV spectrum characteristics and the Dionex column - switching system to analyse the impurities in benzylpenicillin sodium RP - HPLC chromatogram. Results： GFC and RP - HPLC are well unified to find p as the index of the polymer impurity. Conclusion： The analysis of polymer impurities inβ- lactam antibiotics become diverse. And it is helpful to realize more powerful control over polymer impurities inβ- lactam antibiotics.

关 键 词：青霉素有关物质 聚合物杂质 RP—HPLC 凝胶色谱 柱切换 

分 类 号：R917[医药卫生—药物分析学]