凝胶色谱法分离哌拉西林钠聚合物杂质  

Isolation of polymer impurities in piperacillin sodium by polystyrene-based gel filtration chromatography

作　　者：倪静文[1] 魏荣卿[1] 刘晓宁[1] 方硕[1] 袁耀佐[2] 张玫[2] 

机构地区：[1]南京工业大学生物与制药工程学院色谱中心,南京210009 [2]江苏省药品检验所,南京210008

出　　处：《中国抗生素杂志》2011年第2期135-138,148,共5页Chinese Journal of Antibiotics

基　　金："国家高技术研究发展专项经费资助"项目(No.2007AA02Z200;2007AA06A402)

摘　　要：目的建立聚苯乙烯基质的凝胶色谱柱(MKF-GPC-300)对哌拉西林钠中的聚合物杂质(或称缩合物杂质)的分离分析方法。方法凝胶色谱柱为MKF-GPC-300柱(300mm×7.8mm,5μm),流动相为0.01mol/L醋酸铵缓冲液(pH7.0):乙腈(65:35),流速1.0mL/min,检测波长254nm。结果哌拉西林钠与其缩合物杂质基线分离(分离度2.62),缩合物峰柱效大于3000且对称性良好(对称性1.11),分析周期耗时不到12min。结论本方法可以迅速、简便地用于哌拉西林钠缩合物杂质的分离分析。Objective To establish a method for isolation and detection of polymer impurity（condensation impurity） in piperacillin sodium by polystyrene gel（MKF-GPC-300）. Methods MKF-GPC-300 （300mm×7.8mm,5μm） column was used. Mobile phase was 0.01mol/L ammonium acetate buffer （pH7.0）： acetonitrile （65： 35, V/V）. Flow rate was 1.0 mL/min and the detection wavelength was 254nm. Results The resolution between the peak of piperacillin sodium and the peak of its polymer impurities which with good symmetry（1.11） was 2.62, and the plates of the polymer impurities＇ peak were more than 3000. In addition, the process of analysis was less than 12 minutes. Conclusion This method can be applied for rapid determination of condensation impurity in piperacillin sodium.

关 键 词：聚苯乙烯凝胶 MKF-GPC-300 哌拉西林钠 聚合物杂质 缩合物杂质 

分 类 号：R927.2[医药卫生—药学]