摘要
目的:建立高效液相色谱法建检查恩替卡韦原料中的三种光学异构体。方法:使用Chiralpak AD-H手性柱(4.6mm×250mm,5μm),乙醇-甲醇-正庚烷-三乙胺(42.5∶2.5∶55∶0.1)为流动相,流速为每分钟0.6mL·min-1,检测波长为254nm。结果:3种异构体和恩替卡韦能够被有效分离。结论:本方法可较快的拆分恩替卡韦的3种异构体,可用来控制恩替卡韦原料药中异构体的限度。
Objective：To develop an HPLC method for the three optical isomerisms separation of entecavir. Methods： Chiralpak AD-H（4.6 mm×25 mm,5 μm）with the mobile phase consisting of ethanol-methanol-n-heptane-triethylamine （42.5∶2.5∶55∶0.1） was used. The wavelength was set at 254 nm and the flow rate was kept at 0.6 mL·min-1.Results： Three isomerisms were completely separated and determined. Conclusion： The method was quickly to separated the three isomerisms of entecavir. and was applicable to the purity determination of entecavir.
出处
《中国药品标准》
CAS
2010年第6期423-425,共3页
Drug Standards of China
