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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 a method for the determination of three optical isomers in Y101 tablets by high performance liquid chromatography. METHODS: DAICEL CHIRALPAK AD-H chiral column (250 mm × 4.6 mm, 5 μm) was used with the mobile phase of n-hexane-isopropanol-diethylamine at a flow rate of 0.8 mL · min- The column temperature was 30 ℃, the detection wavelength was 226 nm and the injection volume was 40μL. Results: The separation of Y101 and three optical isomers was good. 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 simple, accurate and can be applied to the determination of three optical isomers in Y101 tablets and to control the limits of their isomers.