HPLC同时测定米格列醇片有关物质和含量的方法改进研究

目的：改进米格列醇片有关物质和含量的HPLC检测方法,建立经方法学验证的新方法。方法：采用Lichro-spher氨丙基硅烷键合硅胶柱（250 mm×4.6 mm,5μm）;以乙腈-0.01 mol/L磷酸二氢铵溶液（三乙胺调pH值至7.5）（65∶35）为流动相;流速1.0 ml/min;检测波长为210 nm;柱温25℃;进样量20μl;二极管阵列检测器（DAD）检测。结果：米格列醇与其杂质完全分离,重复进样时米格列醇的峰面积及保留时间稳定。结论：本法专属性强、灵敏度高、准确度和重复性好、方法简便,可作为米格列醇片有关物质和含量测定的检测方法。

Study on improving the HPLC method of simultaneous deter-mination of the related compounds and assay for miglitol tablets

Objective: To improve the HPLC method on the related compounds and assay for Miglitol tablets,set up the new method of methodology validation.Methods: The amino-propyl silane bonded silica column(250 mm×4.6 mm,5 μm) was used.The mobile phase was acetonitrile-0.01 mol/L ammonium dihydrogen phosphate solution(adjusted the pH to 7.5 with triethylamine)(65∶35).The flow rate was 1.0 ml/min and the DAD detector was set at 210 nm.The column temperature was maintained at 25℃ and the injection volume was 20 μl.Results: The peaks of miglitol and its impurities were completely separated and the peak area and the retention time of miglitol remained stable when the injections were repeated.Conclusion: The method is specific,sensitive,accurate,simple and more suitable for the determination of the related compounds and assay for miglitol tablets.