手性固定相HPLC法分离索氟布韦的对映异构体

A Chiral Stationary Phase HPLC Method for Enantiomers Separation in Sofosbuvir

目的:建立索氟布韦对映异构体的检测方法。方法:采用CHIRALPAK AD-H 250×4.6 mm,5μm手性色谱柱,以正己烷-异丙醇(65∶35,体积比)为流动相;流速为0.5 mL/min,检测波长为260 nm,柱温为40℃。结果:索氟布韦与异构体之间最小分离度为3.9,且峰面积与浓度在一定的范围内均呈良好的线性关系。结论:该方法可用于索氟布韦与异构体的分离,并且专属性强、灵敏度高,能够准确、可靠的定量检测原料药中的异构体。

Objective:To establish a method for the determination of the enantiomers of sofosbuvir.Methods:A CHIRALPAK AD-H 250×4.6 mm 5μm chiral column was used with n-hexane-isopropanol(65∶35)as mobile phase.The flow rate was 0.5 mL/min,the detection wavelength was 260 nm,and the column temperature was 40℃.Results:The minimum separation degree between sofosbuvir and isomer was 3.9,and the linear relationship between the peak area and concentration was good in a certain range.Conclusion:The method can be used for the separation of sofosbuvir from isomers with high specificity and sensitivity,and can be used for the accurate and reliable quantitative determination of isomers in API.