盐酸罗格列酮片中有关杂质的分析及表征  

Analysis and characterization of related impurities inRosiglitazone hydrochloride tablets

作　　者：郑媛媛 聂鹏 ZHENG Yuanyuan;NIE Peng(Guizhou Institute for Food and Drug Control,Guiyang,Guizhou 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004

出　　处：《贵州师范大学学报（自然科学版）》2023年第4期64-70,共7页Journal of Guizhou Normal University：Natural Sciences

基　　金：贵州省科学技术基金资助项目(黔科合基础-ZK[2021]一般041号)。

摘　　要：通过Q-TOF型液质联用仪和高效液相色谱仪分析盐酸罗格列酮片可能包含的3个杂质,并分析其可能来源。结果显示:质谱结果中,分子量256.106 5可能为杂质A、分子量373.084可能为杂质B、分子量343.075 6可能为杂质C;通过相关文献和对照品比对确定了杂质A的分子结构,同时推理了杂质B、杂质C的可能来源;经分析,杂质A和杂质C可能是工艺杂质,杂质B可能是降解杂质,该结果有利于提升盐酸罗格列酮片的检验标准。The three possible impurities in rosiglitazone hydrochloride tablets were analyzed by Q-TOF LC-MS and HPLC,and their possible sources were also analyzed.The result shows:In the mass spectrometry results,the molecular weight 256.1065 was impurity A,373.084 possibly impurity B,343.0756 possibly impurity C.The molecular structure of impurity A was determined through literature investigation and comparison of reference products,and the possible sources of impurities B and C were deduced based on relevant literature reports.After analysis,impurities A and C may be process impurities,and impurity B may be degradation impurities.These series of results laid a solid synthetic chemical foundation for improving the test standard of rosiglitazone hydrochloride tablets.

关 键 词：罗格列酮 杂质 结构表征 来源 

分 类 号：R917[医药卫生—药物分析学] Q58[医药卫生—药学]