高效液相凝胶色谱法测定阿莫西林中的高分子杂质  

Determination of high molecular weight impurities in Amoxicillin by gel filtration chromatography

作　　者：李哲媛[1] 李玉凤[1] 范兵[1] 傅文[1] 向金莲[1] 

机构地区：[1]云南省药品检验所,云南昆明650011

出　　处：《华西药学杂志》2005年第1期52-54,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的　建立测定阿莫西林中高分子杂质的方法。方法　采用OhpakSB 80 .2 5HQ(聚合基柱 )凝胶色谱柱 ,以 0 .1mol·L-1磷酸盐缓冲液 (pH 7 .0 )为流动相 ,外标法定量。结果　建立了在该系统下以分子量最大的杂质作为阿莫西林中的信号杂质进行质量控制。结论　所用方法简便 ,结果可靠 ,可以用于阿莫西林中高分子杂质的检测。OBJECTIVE To develop a method for the determination of high molecular weight impurities in Amoxicillin.METHODS Gel filtratin chromatography method was adpoted. The analytical column was Ohpak SB-802.5(8.0 mm×300 mm, Japan) and the mobile phase was phosphate buffer (pH 7.0, 0.1 mol·L -1). The concentration of impurities was quantified by external standard method. RESULTS The impurity with the highest molecular weight in Amoxicillin was chosen as the index to evaluate high molecular weigh impurities. CONCLUSION The method is simple, rapid and reliable.It is applicable for the quality control of Amoxicillin.

关 键 词：阿莫西林 高分子杂质 高效液相 HQ 磷酸盐缓冲液 凝胶色谱法 定量 聚合 外标法 基柱 

分 类 号：R927[医药卫生—药学] R573