关于氯碘羟喹有关物质检查的研究

Study on Determine of Related Substances in Clioquinol

目的:采用高效液相法对氯碘羟喹中的有关物质进行测定。方法:采用Ace5C8(4.6mm×150mm,5μm)色谱柱;流动相为缓冲盐溶液(称取0.50g的乙二胺四乙酸二钠,用400mL水溶解,加入0.25mL三乙胺,用磷酸调pH值至3.0)-甲醇(35∶65);柱温为30℃;检测波长为254nm。结果:国内生产企业A的样品有关物质含量为31.45%,国外生产企业B的样品有关物质含量为3.07%。结论:建议《中国药典》增加氯碘羟喹有关物质检查。

Obejective：To establish an HPLC method to determine the content of related substances in Clioquinol. Methods：Ace 5 C8 （4. 6 mm×150 mm,5 μm） co/unto ; mobile phase：buffer salt （ Dissolve 0. 50 g of EDTA in 400 mL of water, add 0. 25 mL of triethylamine, adjust to pH 3.0 with phosphoric acid. ）-methanol （35：65 ）; Column Temperature： 30 ℃; detective wavelength： 254 nm. Results：The content of related substances in Clioquinol of enterprise A and B are 31.45% and 3.07% , respectively. Conclusion：Chp should increase related substances in Clioquinol.