首批阿戈美拉汀国家对照品的研制
Standardization of the first batch of national reference standard of agomelatine
孙长迎 1文强 1张燕霞 2尹利辉1
作者信息
- 1. 中国食品药品检定研究院,北京 102629;国家药品监督管理局化学药品质量研究与评价重点实验室,北京 102629
- 2. 江苏豪森药业集团有限公司,连云港 222000
- 折叠
摘要
目的:建立定性和定量用阿戈美拉汀的首批国家对照品.方法:应用IR光谱、气质联用及NMR技术对阿戈美拉汀进行结构确证.采用HPLC法测定纯度并且对均匀性、稳定性进行研究,并测定干燥失重、炽灼残渣、热重分析等,通过质量平衡法计算阿戈美拉汀含量.结果:确证阿戈美拉汀的结构,确定首批阿戈美拉汀对照品含量为 99.9%,与核磁定量法测定的结果、高氯酸非水滴定结果、差示扫描量热法(differential scanning calorimetry,DSC)结果基本一致.结论:首批阿戈美拉汀国家对照品的研制可作为阿戈美拉汀原料及其相关制剂的鉴别和含量测定用对照品.
Abstract
Objective:To establish the first batch of national reference standard of agomelatine for qualitative and quantitative determination.Methods:The structure of agomelatine was confirmed by IR,NMR an d GC-MS spectroscopy.The purity of agomelatine was determined by HPLC,and the homogeneity and stability were studied.Moreover,the drying weight loss and residual ignition were determined.The content of agomelatine was calculated by mass balance method.Results:The structure of agomelatine was confirmed.The content of agomelatine was assigned as 99.9%,which was basically consistent with the results of nuclear magnetic resonance quantitative method,perchloric acid non-aqueous titration and DSC.Conclusion:The first batch of national reference standard of agomelatine can be applied for the identification and content determination of agomelatine and its related preparations.
关键词
阿戈美拉汀/对照品/含量测定/HPLC法/质量平衡法Key words
agomelatine/reference standard/content determination/HPLC/mass balance methods引用本文复制引用
基金项目
国家药品监督管理局化学药品质量研究与评价重点实验室科研资助项目(2023HYZX26)
出版年
2024
NETL
NSTL
万方数据