注射用奥美拉唑中微量EDTA的检查

Examination of the trace EDTA in omeprazole for injection

目的:建立注射用奥美拉唑中微量 EDTA 的检查方法。方法:采用化学显色法。本法根据 EDTA 能与镍离子形成稳定的无色可溶性络合剂,阻止镍离子与丁二酮肟生成粉红色络合物,从而检出微量的 EDTA。结果:该法和中国药典标准规定的硫氰酸铵-三氯化铁显色法在测定15 mg 以上的 EDTA 时,测定结果一致。硫氰酸铵-三氯化铁显色法的最低检测限为15mg,而该法的最低检测限为0.15 mg,灵敏度提高了100倍,可检出低于15 mg 微量 EDTA。结论:该方法简便、灵敏、准确,可快速检查注射剂中的微量 EDTA。

Objective：To develop a method for examining the trace EDTA in omeprazole for injection. Method：The nickel chemical coloration was adopted. This method examined the trace EDTA according to that EDTA could form stable colorless chelating agent and prevent the nickel ion producing pink deposition with butanedione dioxime. Resuits ：The result was in accordance with the chemical coloration of ammonium thiocyanate -ferric chloride method for the test of EDTA in the Chinese Pharmacopoeia. The lowest detection limit of ammonium thiocyanate - ferric chloride method was 15 mg,but this method was 0. 15 mg,which showed this method was more sensitive with a lower detective limit. Conclusions：The method is simple,sensitive,and it can be used to examine the trace EDTA in omeprazole for injection.