HPLC测定甲磺酸二氢麦角碱缓释片有关物质

An Analytical Method for Related Substances in Dihydroergotine Methanesulfonate Sustained Release Tablets by HPLC

目的:建立并优化甲磺酸二氢麦角碱缓释片有关物质的HPLC测定色谱方法。方法:采用单因素方法筛选样品前处理条件、HPLC检测的色谱条件,重点优化了流动相pH值,缓冲盐浓度及洗脱梯度。结果:所开发的方法,专属性强,对样品和降解产物可有效分离,峰纯度和物料平衡均符合要求。结论:该测定方法操作简便、准确,可用于甲磺酸二氢麦角碱缓释片有关物质的测定。

Objective:To established and optimized a HPLC method for the determination of related substances in dihydroergot methanesulfonate sustained-release tablets.Methods:A single factor method was used to screen and develop sample processing methods.The chromatographic conditions for HPLC detection were optimized,with a focus on optimizing the mobile phase pH value,buffer salt concentration,and elution gradient.Results:The developed method was highly specific and could effectively separate samples and degradation products,and the peak purity and mass balance were satisfactory.Conclusion:This method was simple and accurate,and could be used for the determination of related substances in dihydroergot methanesulfonate sustained-release tablets.