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

作　　者：张发成 张丹[2] 管岚 万竹青 蒋雪琴 Zhang Facheng;Zhang Dan;Guan Lan;Wan Zhuqing;Jiang Xueqin(Polifarma(Nanjing)Co.,Ltd.,Nanjing 210038,China;Nantong University,Nantong 226001,China)

机构地区：[1]宝利化(南京)制药有限公司,江苏南京210038 [2]南通大学,江苏南通226001

出　　处：《云南化工》2024年第2期88-92,共5页Yunnan Chemical Technology

摘　　要：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.

关 键 词：甲磺酸二氢麦角碱 缓释片 有关物质 方法开发 

分 类 号：TQ460[化学工程—制药化工]