The impurity profiling of simvastatin and its tablets by UPLC-MS/MS / 药学学报
Acta Pharmaceutica Sinica
; (12): 672-678, 2014.
Article
in Zh
| WPRIM
| ID: wpr-245028
Responsible library:
WPRO
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.
Full text:
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Index:
WPRIM
Main subject:
Quality Control
/
Tablets
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Chemistry
/
Drug Contamination
/
Chromatography, High Pressure Liquid
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Simvastatin
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Spectrometry, Mass, Electrospray Ionization
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Tandem Mass Spectrometry
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Chromatography, Reverse-Phase
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Hypolipidemic Agents
Language:
Zh
Journal:
Acta Pharmaceutica Sinica
Year:
2014
Type:
Article