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 gra-dient.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 sub-stances in dihydroergot methanesulfonate sustained-release tablets.
关键词
甲磺酸二氢麦角碱/缓释片/有关物质/方法开发
Key words
dihydroergotoxine methanesulfonate/sustained release tablets/related substances/method development
维普
万方数据