高效液相色谱法测定依托度酸缓释片中的有关物质

目的:建立以高效液相色谱法测定依托度酸缓释片中有关物质的方法。方法:色谱柱为C18,流动相为甲醇-乙腈-0.055mol/L醋酸铵溶液(60∶40∶900)与甲醇-乙腈-0.5mol/L醋酸铵溶液(540∶360∶100),并进行梯度洗脱,流速为1.0ml/min,柱温为35℃,检测波长为220nm,进样量为10μl。结果:各项专属性试验中,依托度酸主峰与其它杂质峰均分离较好;3批样品中各杂质的检测均符合依托度酸缓释片中有关物质检查的要求。结论:本方法可用于依托度酸缓释片中有关物质的检测。

Determination of the Related Substances in Etodolac Sustained Released Tablets by HPLC

OBJECTIVE:To establish HPLC method in the determination of the related substances in etodolac sustained released tablets.METHODS:The determination was performed with C 18 as the chromatographic column.The mobile phases consisted of methanol-acetonitrile-0.055mol/L ammonium acetate solution(60∶40∶900)and methnol-acetonitrile-0.5mol/L ammonium acetate solution(540∶360∶100),which were subjected to gradient elutions.Its flow rate of was1.0ml/min,the column temperature was35℃,the detection wavelength was220nm and the sample size was10μl.RESULTS:The main peaks of etodolac and the other peaks of the related foreign substances could be well isolated in all the specificity tests.The determination of the related substances of the3batches of samples can satisfy the determination requirements for the related substances in etodolac sustained released tablets.CONCLUSION:This method can be applied to determine the related subˉstances in etodolac sustained released tablets.