首页|HPLC测定甲磺酸二氢麦角碱缓释片有关物质

HPLC测定甲磺酸二氢麦角碱缓释片有关物质

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

dihydroergotoxine methanesulfonatesustained release tabletsrelated substancesmethod development

张发成、张丹、管岚、万竹青、蒋雪琴

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宝利化 (南京) 制药有限公司, 江苏 南京 210038

南通大学, 江苏 南通 226001

甲磺酸二氢麦角碱 缓释片 有关物质 方法开发

2024

云南化工
云南省化工研究院 云天化集团有限责任公司 云南煤化工集团有限公司 云南省化学化工学会

云南化工

影响因子:0.272
ISSN:1004-275X
年,卷(期):2024.51(2)
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