HPLC法测定阿托伐他汀钙及中间体L1的有关物质

Determination of the related substances of atorvastatin calcium and intermediate L1 by HPLC

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。

Abstract: 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.