凝胶色谱法测定阿莫西林颗粒中的高分子杂质

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

目的：建立测定阿莫西林中的高分子杂质（阿莫西林聚合物）的方法。方法采用凝胶色谱法。色谱柱为Sephadex G-10（40～120mm）凝胶柱，流动相A为0．2mol／L磷酸盐缓冲液（pH8．0），流动相B为水，流速为1．0ml／min；检测波长为254nm。结果阿莫西林颗粒中的高分子杂质含量，均小于0．1％。结论方法灵敏、准确、简便，可用于本品的质量控制，对提高临床有效性及安全性有利。以此方法测定已在国内上市的两个厂家阿莫西林颗粒的高分子杂质，结果发现，南京长澳制药有限公司的产品高分子杂质含量低于香港联邦制药厂的产品。

Objective： To develop a method for the determination of high molecular weight impurities in. Methods： Gel filtration chromatography was adopted. The analytical column was Sephadex G-10 gel column. The mobile phase was consisted of A, 0.2mol/L phosphate buffer （pH8.0） and B, water. The flow rate was 1.0ml/min. The detection wavelength was at UV 254nm. Resutls： The content of high molecular weight impurities in Amoxicillin Granduls is less than 0.1%. Conclusion： The method is sensitive, accurate, simple and convenient enough to be used for the quality control of Amoxicillin Granduls.