氢溴酸伏硫西汀首批国家对照品的研制  

Development of the First Batch of National Reference Standard of Vortioxetine Hydrobromide

作　　者：彭玉帅 孙长迎 文强 赵文[1] 左宁[1] 尹利辉[1] PENG Yushuai;SUN Changying;WEN Qiang;ZHAO Wen;ZUO Ning;YIN Lihui(NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,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

出　　处：《中国药学杂志》2024年第18期1735-1740,共6页Chinese Pharmaceutical Journal

基　　金：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项目资助(2023HYZX26);2023年度国家药品标准制修订研究课题资助(2023Y12,2023Y15)

摘　　要：目的研制定量和定性用氢溴酸伏硫西汀首批国家对照品。方法采用核磁共振波谱、高分辨质谱、红外光谱和紫外光谱进行结构确证,采用2种高效液相色谱(HPLC)系统进行有关物质分析,用面积归一化法、主成分自身对照法计算HPLC纯度,采用HPLC法对均匀性、稳定性进行研究,并采用多种方法对其他理化性质进行考察,应用质量平衡法对该对照品进行赋值,并通过核磁共振定量法和差示扫描量热法(DSC)对含量结果的准确性进行验证。结果确证了氢溴酸伏硫西汀首批国家对照品的结构,并测定其含量为99.9%。结论研制的首批定量和定性用氢溴酸伏硫西汀国家对照品,可满足氢溴酸伏硫西汀原料及其制剂的质量控制需要。OBJECTIVE To establish the first batch of national reference standard for quantitative and qualitative analysis of vortioxetine hydrobromide.METHODS The structure of vortioxetine hydrobromide was identified by means of 1H-NMR,13C-NMR,MS,IR and UV.HPLC purity was calculated via peak area normalization and principal component self-comparison.The homogeneity and stability were studied by HPLC,and other physicochemical properties were investigated using various analytical methods.The content was determined using mass balance method and verified by NMR quantitative method and differential scanning calorimetry.RESULTS The structure of the first batch of national reference substance of vortioxetine hydrobromide was confirmed and its content was determined to be 99.9%.CONCLUSION The development of the first batch of national reference substance of vortioxetine hydrobromide can meet the quality control requirements of raw material and preparations of vortioxetine hydrobromide.

关 键 词：氢溴酸伏硫西汀 对照品 结构确证 质量平衡法 核磁共振定量 

分 类 号：R917[医药卫生—药物分析学]