HPLC法测定创新药Y101片剂中3个光学异构体的含量

HPLC determination of three optical isomers in Y101 tablets

目的:建立高效液相色谱法测定Y101片剂中3个光学异构体含量的方法。方法:采用DAICEL CHIRALPAK AD-H手性柱(250 mm×4.6 mm,5μm),流动相为正己烷-异丙醇-二乙胺(85∶15∶0.1),流速0.8 mL.min-1,柱温30℃,检测波长226 nm,进样量40μL。结果:Y101与3个光学异构体分离良好,Y101检测浓度的线性范围为0.1042～0.8336μg.mL-1(r=0.9999),检测限为2.9176 ng。结论:该方法操作简便,结果准确,可用于Y101片剂中3个光学异构体的含量测定并控制其异构体的限度。

Objective：To establish an HPLC method for the determination of three optical isomers in Y101 tablets. Method ：The separation was performed on an DAICEL CHIRALPAK AD - H ehiral column （250 mm x 4. 6 mm, 5 txm）. The mobile phase was n -hexane -/so -propylaleohol -diethylamine（85： 15： 0. 1 ）at a flow rate of 0. 8 mL· min^-1. The column temperature was 30℃, and the detection wavelength was set at 226 nm. The injection volume was 40 μL. Results：Y101 and three optical isomers were well separated. The linear range of Y101 was 0. 1042 -0. 8336μg · mL^-1 （r =0. 9999） ,the detection limit was 2. 9176 ng. Conclusion：The method is proved to be simple and accu- rate ,which is suitable for the content determination and purity determination of three optical isomers in Y101 tablets.