The impurity profiling of simvastatin and its tablets by UPLC-MS/MS.
- Author:
Jie LI
;
Hai-Wei HUANG
;
Hong ZHANG
;
Tao LI
;
Ya-Qin SHI
- Publication Type:Journal Article
- MeSH:
Chromatography, High Pressure Liquid;
Chromatography, Reverse-Phase;
Drug Contamination;
Hypolipidemic Agents;
chemistry;
Quality Control;
Simvastatin;
chemistry;
Spectrometry, Mass, Electrospray Ionization;
Tablets;
Tandem Mass Spectrometry
- From:
Acta Pharmaceutica Sinica
2014;49(5):672-678
- CountryChina
- Language:Chinese
-
Abstract:
Investigation of simvastatin and its related substances was carried out using a reversed phase ultra performance liquid chromatography/tandem mass spectrometry method. The identification of impurities in simvastatin was performed with a triple-quadrupole mass spectrometer, with an electrospray ionization (ESI) source in the negative/positive ion mode. A total of 12 compounds were characterized in commercial samples, among which 2 impurities had never been reported. All the impurities were deduced based on the MS fragment pathways of simvastatin and the biosynthetic pathway of lovastatin. This work provides very useful information for quality control of simvastatin.
