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辛伐他汀片中某未知杂质LC-MS定性分析
引用本文:胡兵,黄碧海,单晓芸,黄偲. 辛伐他汀片中某未知杂质LC-MS定性分析[J]. 中国药师, 2013, 16(9): 1357-1358
作者姓名:胡兵  黄碧海  单晓芸  黄偲
作者单位:1. 武汉市食品药品检验所,武汉,430012
2. 武汉宏韧医药科技有限公司
摘    要:目的:对辛伐他汀片中某一未知杂质进行定性分析.方法:用HPLC-MS对辛伐他汀片中一未知杂质进行定性分析.结果:根据HPLC-MS信息确定杂质结构.结论:该杂质为辛伐他汀酸乙酯.

关 键 词:辛伐他汀片  未知杂质  定性分析  液质联用
修稿时间:2013-07-05

Qualitative Analysis of an Unkown Impurity in Simvastatin Tablets by LC-MS
Hu Bing , Huang Bihai , Shan Xiaoyun , Huang Cai. Qualitative Analysis of an Unkown Impurity in Simvastatin Tablets by LC-MS[J]. China Pharmacist, 2013, 16(9): 1357-1358
Authors:Hu Bing    Huang Bihai    Shan Xiaoyun    Huang Cai
Affiliation:Blha Shan Xlaoyun, Huang Cai2 (1. Wuhan Institute for Food and Drug Control, Wuhan 430012, China ;2. Wuhan Hongren Medicine Teehnology Co. Ltd. )
Abstract:ABSTRACT Objective: To qualitatively analyze a certain unknown impurity in simvastatin tablets. Method:The structure of the unknown impurity was qualitatively analyzed by HPLC-MS.Result:The structure of the impurity was determined preliminarily by the information of HPLC-MS. Conclusion:The impurity is defined as simvastatin acid ester.
Keywords:Simvastatin tablets   Unknown impurity   Qualitative analysis   LC-MS
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