摘要
为了考察阿托伐他汀钙及其重要中间体L1的有关物质,合成了14个相关化合物,并建立了L1良好的HPLC分离条件(采用C18色谱柱,以水-乙腈-四氢呋喃-甲醇(36∶8.4∶29∶26.6)为流动相,检测波长246 nm)。结果显示中间体L1有4种潜在有关物质,阿托伐他汀钙有10种潜在有关物质。所建立的方法准确度高、重复性良好,适用于阿托伐他汀钙及中间体L1的有关物质检测。
To investigate the related substances of atorvastatin calcium（ATV-Ca）and it′s key intermediate L1, 14 related substances were synthesized, and an HPLC method was developed by using a C18 column, the mobile phase of H2O-CH3CN-THF-MeOH（36 ∶8. 4 ∶29 ∶26. 6）, and the detection wavelength of 246 nm. There were 4 potential impurities in intermediate L1 and 10 potential impurities in ATV-Ca; The established methods were accurate and reproducible, which could be used for analysing the related substances in atorvastatin calcium and its key intermediate L1.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2014年第1期70-75,共6页
Journal of China Pharmaceutical University
