快速测定新药阿司匹林铜中的杂质水杨酸铜

Quick determination of copper salicylate in copper aspirinate

目的 建立一种快速分析水杨酸铜的方法 ,用于生产过程的质量控制。方法 通过络合溶解、溶剂萃取、光度法测量的联用 ,测定水杨酸的量 ,再换算成水杨酸铜的含量。结果 方法的测定范围为 0 .1%～ 5 % ,回收率 97%～ 10 4% ,RSD <3 .3%。结论 方法简单、快速、准确 ,适用于阿司匹林铜生产过程的质量控制。

OBJECTIVE To establish an analytical method of copper salicylate which can be applied to the quality control of copper aspirinate during the synthesis process.METHODS By combinaton of complexing dissolution,solvent extraction and photometric measurement,the amount of salicylic acid was first obtained and then converted to the content of copper salicylate.RESULTS The analysis limitation of copper salicylate was between 0.1%～5% and the recovery varied from 97%～104% with RSD lessthan 3.3%.CONCLUSION The established method here was simple,rapid and accurate,suitable for mornitoring the synthesis process of copper aspirinate.