辛伐他汀片中某未知杂质LC-MS定性分析

Qualitative Analysis of an Unkown Impurity in Simvastatin Tablets by LC-MS

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。

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.