阿莫西林中高分子杂质的测定与质量分析  

Studies on the separation and quality of high molecular weight impurities in amoxicillin

作　　者：李哲媛[1] 李玉凤[1] 范兵[1] 向金莲[1] 

机构地区：[1]云南省药品检验所,昆明650011

出　　处：《中国现代应用药学》2006年第4期326-327,共2页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的比较不同厂家阿莫西林原料、胶囊、混悬剂中高分子杂质的含量。方法采用OhpakSB-802.5HQ(聚合基柱)高效液相凝胶色谱系统进行分离分析。结果21批阿莫西林样品中高分子杂质的测定结果均为1%以下。结论国产与进口阿莫西林中的高分子杂质含量无显著差异。OBJECTIVE To develop a method for determination the high molecular impurities in amoxieillin to evaluate the quality of amoxieillin and its capsule or suspension. METHODS Determination of high molecular impurities using Ohpak SB-802.5HQ gel filtration chromatography was established. RESULTS 21 batehas of amoxieillin were analyzed. The contents of the high molecular impurities were all less than 1%. CONCLUSION Results of analysis showed there were no significant differents in the contents of impurities between domestic and imported.

关 键 词：阿莫西林 高分子杂质 凝胶色谱 

分 类 号：R917.795.1[医药卫生—药物分析学]