反相高效液相色谱法测定米格列醇片的有关物质

Determination of the related substances of Miglitol Tablets by RP-HPLC

目的:建立一种简便、准确的方法(RP-HPLC法)测定米格列醇片的有关物质。方法:采用反相高效液相色谱法,用自身对照法计算米格列醇片有关物质的量。用AstecCYCLOBONDI2000(250mm×4.6mm,5μm)色谱柱,以0.115%磷酸二氢钠(NaH2PO4·H2O)溶液-乙腈(20:80)为流动相,于波长为205nm处检测。结果:米格列醇与其杂质完全分离,有关物质的线性回归方程为:A=5.22×103C+2.52×103,r=0.9999(n=5);方法的最低检出限为3.836ng。结论:实验证明该法简便快捷,能准确地测定样品的有关物质。

Objective：To establish a more simple、nicety method（RP-HPLC）to determine the related substances of Miglitol Tablets.Methods：Astec CYCLOBOND I 2000 column was used,with acetonitrile-0.115% sodium dihydrogen phosphate monohydrate as mobile phase;the flow rate was 1.0mL/min and the detection wavelength was 205nm.The related substances was quantified by self-calibrated method.Results：The peaks of Miglitol and its impurities were completely separated;the regression equation for related substances of Miglitol was A=5.22×103C＋2.52×103,r=0.9999（n=5）;The detection limit was3.836ng.Conclusions：This method is convenient,quick and reproducible for the quantitative determination of Miglitol in the related substances.