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UPLC-MS/MS法研究国产辛伐他汀及片剂的杂质谱

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采用超高效液相-三重四级杆质谱联用技术对国内上市的辛伐他汀及其片剂的杂质谱杂质进行分析.本研究共确证了辛伐他汀的12个杂质,其中2个杂质为新化合物.所有杂质均以辛伐他汀和洛伐他汀的质谱裂解途径为模板,进行了质谱解析.该研究为辛伐他汀生产过程中的杂质控制和质量标准的有效制订提供了详实的数据支持.
The impurity profiling of simvastatin and its tablets by UPLC-MS/MS
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.

simvastatinimpurity profilingUPLC-MS/MS

李婕、黄海伟、张红、李涛、施亚琴

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中国食品药品检定研究院,北京100050

国家药典委员会,北京100061

辛伐他汀 杂质谱 UPLC-MS/MS

2014

药学学报
中国药学会 中国医学科学院药物研究所

药学学报

CSTPCDCSCD北大核心
影响因子:1.274
ISSN:0513-4870
年,卷(期):2014.49(5)
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