米格列醇片溶出度HPLC检测方法改进研究

目的：改进米格列醇片溶出度的HPLC检测方法,建立经方法学验证的新方法。方法：采用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,可作为米格列醇片溶出度测定的检测方法。

Improvement of an HPLC method for determination of dissolution of miglitol tablets

Objective:To improve an HPLC method for determination of the dissolution of Miglitol tablets.Methods:The amino-propyl silane bonded silica column(250 mm×4.6 mm,5 μm) was used as stationary phase,and a mixture of acetonitrile and 0.01 mol/L ammonium dihydrogen phosphate solution(35∶65),the pH of which was adjusted to 7.5 with triethylamine,as mobile phase.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:Miglitol and 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 dissolution for miglitol tablets.