HPLC法检查米格列奈对映异构体限量

Determination of the enantiomers of mitiglinide by HPLC

目的:建立高效液相色谱法检查米格列奈对映异构体限量的方法。方法:采用Sumichiral OA-3300(4 mm×250mm,5μm)为手性色谱柱,以正己烷-氯仿-甲醇-三氟醋酸(50∶48∶2∶0.5)为流动相,检测波长为259 nm,流速为1 mL/min。结果:米格列奈与对映异构体达到了较好的分离,其分离度为1.9,对映异构体的最小检出量为30 ng;对映异构体峰面积与浓度线性关系良好,回归方程为A=2.593 4×103c+2.672×102(r=0.999 7,n=5)。结论:该法快速、准确,可用于米格列奈对映异构体的检查与控制。

Aim：To establish an HPLC method to determine the contents of the enantiomers of mitiglinide. Methods： The chromatographic separation of the enantiomers of mitiglinide was performed on a Sumichiral OA-3300 column （4 mm×250 mm, 5 μm） with hexane-chloroform-methanol-trifluoroacetic （50 ： 48 ： 2 ： 0.5） as the mobile phase and the flow rate of 1.0 mL/min. The elution was monitored at the wavelength of 259 nm. Results： The enantiomers were separated with the resolution of 1.9. The limit of detection was 30 ng. There existed good liner relationship between the peak area and the response with the calibatration equation of A = 2. 593 4×10^3 c ＋ 2. 672×10^2 （ r = 0. 999 7, n = 5）. Conclusion ： The established method is quick, accurate and can be used for the determination and control of the enantiomers of mitiglinide.