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
分类号：
出版年·卷·期（页码）：2013,33 (2):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
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,5 μm),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40 μL。 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0.1042~0.8336 μg·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。
-----英文摘要：---------------------------------------------------------------------------------------
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 chiral column(250 mm×4.6 mm,5 μm).The mobile phase was n-hexane-iso-propylalcohol-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 0.1042-0.8336 μg·mL-1(r=0.9999),the detection limit was 2.9176 ng. Conclusion: The method is proved to be simple and accurate,which is suitable for the content determination and purity determination of three optical isomers in Y101 tablets.
-----参考文献：---------------------------------------------------------------------------------------
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