阿莫西林胶囊中高分子聚合物测定方法的改进-中国药房.PDFVIP

阿莫西林胶囊中高分子聚合物测定方法的改进 ＊ 蒋 婷 ，袁明勇，郑玲利（成都医学院第一附属医院，成都 610500） 中图分类号 R927.2 文献标志码 A 文章编号 1001-0408（2013）33-3152-03 DOI 10.6039/j.issn. 1001-0408.2013.33.29 摘 要 目的：改进2010年版《中国药典》中阿莫西林胶囊中高分子聚合物的测定方法。方法：采用反相高效液相色谱法，使用高 效凝胶色谱柱TSK-GEL G2000SWXL 代替SephadexG-10凝胶柱，流动相用0.005mol/L 磷酸盐缓冲液（pH 值7.0）-乙腈（等度洗 脱）代替pH 8.0磷酸盐缓冲液-水（梯度洗脱），进样量由20μl 代替100～200μl ，柱温为25℃，检测波长为254nm 。结果：阿莫西林 主峰与高分子聚合物峰实现完全基线分离，分离度大于1.5，分析时间为20min 左右，理论板数不低于2000；阿莫西林检测质量浓 度线性范围为1.528～21.388μg/ml （r ＝0.9999），重复性试验RSD ＝1.27％（n ＝5），检测限为6.012ng 。而原方法理论板数不低于 700，分析时间约为50min 。结论：改进后方法比原方法柱效高、峰形对称，重复性更好，进样量更小，分析时间更短，操作更简便 快捷，且结果可靠。 关键词 阿莫西林胶囊；高分子聚合物；反相高效液相色谱法；分子排阻色谱法；TSK-GEL G2000SWXL 色谱柱；含量测定 Improvement of the Determination Method for High-molecular Polymer in Amoxicillin Capsules JIANG Ting ，YUAN Ming-yong ，ZHENG Ling-li （The First Affiliated Hospital of Chengdu Medical College ， Chengdu 610500，China ） ABSTRACT OBJECTIVE ：To improve the determination method for the high-molecular polymer in Amoxicillin capsules in Chi- nese Pharmacopeia （2010 edition）. METHODS ：RP-HPLC method was adopted. The determination was performed on TSK-GEL G2000SWXL column replacing SephadexG-10 gel column with mobile phase consisted of 0.005 mol/L phosphate buffer solution （pH 7.0）-acetonitrile （isocratic elution ）replacing phosphate buffer solution （pH 8.0）-water （gradient elution ）. The sample size was 20 μl instead of 100-200 μl ，and the column temperature was 25 ℃. The detection wavelength was set at 254nm. RESULTS ：The peak of high-molecular polymer was completely separated from the main peak of amoxicillin ；separation rate was higher than 1.5， and separation time was 20min around ；the number of the theoretical plate was no less than 2 000. The linear range of amoxicillin was 1.528-21.388 μg/ml （r ＝0.999 9）. The RSD of repeatability test was 1.27％ （n ＝5），and the limit of detectio