HPLC法检测阿托伐他汀钙有关物质的含量及光学纯度  

HPLC determination of related substances and enantiomeric purity of atorvastatin calcium

作　　者：张亚平[1,2] 杨淑莲[1,2] 陈芬儿[1,2] 

机构地区：[1]复旦大学化学系复旦大学-DSM [2]复旦大学-华药联合实验室,上海200433

出　　处：《药物分析杂志》2010年第12期2311-2313,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:检测阿托伐他汀钙原料有关物质的含量及光学纯度。方法:采用反相高效液相色谱法,测定阿托伐他汀钙有关物质的含量。色谱条件:色谱柱为KromasilC18(4.6mm×250mm,5μm),流动相:乙腈-四氢呋喃-0.05mol·L-1枸橼酸铵溶液(0.05mol·L-1枸橼酸溶液用氨水调节pH至4.0)(42∶3∶55);同时采用正相高效液相色谱法测定阿托伐他汀钙的光学纯度,色谱柱为CHIRALPAKAD-H(4.6mm×250mm,5μm),流动相:正己烷-乙醇-冰醋酸(90∶10∶0.3),检测波长均为244nm,柱温为35℃。结果:检测3批阿托伐他汀钙样品中双胺、脱氟体、非对映异构体和对映异构体含量分别为0.05%～0.09%,0.16%～0.20%,0.03%～0.05%,0.18%～0.24%。结论:该方法简单、稳定、可靠、专属性强,可用于阿托伐他汀钙有关物质的检测,为阿托伐他汀钙的质量控制提供了新方法。Objective：To establish an HPLC method for the determination of the related substances and enantiomeric purity of atorvastatin calcium.Methods：The liquid chromatographic procedures in the tests for related compounds was performed on the Kromasil C18 column（4.6 mm×250 mm,5 μm）with acetonitrile-tetrahydrofuran（THF）-ammonium citrate pH 4.0（42∶3∶55）as mobile phase.The liquid chromatographic procedures for enantiomeric purity was performed on the CHIRALPAK AD-H column（4.6 mm×250 mm,5 μm）with hexane-dehydrated alcohol-glacial acetic acid（90∶10∶0.3）as mobile phase.The detection wavelength was 244 nm,the column temperature was 35 ℃.Results：The proposed method was applied to the determination of impurities and was found to contain 0.05%-0.09%,0.16%-0.20%,0.03%-0.05%,0.18%-0.24% of the diamine-atorvastatin,desfluoro-atorvastatin,diastereomer-atorvastatin and enantiomer-atorvastatin.Conclusion：The method is simple,selectivity and reliable,which provide new ways for the quality control of atorvastatin calcium.

关 键 词：阿托伐他汀钙 HPLC 双胺 脱氟体 非对映异构体 对映异构体 

分 类 号：R917[医药卫生—药物分析学]