米格列醇片溶出度HPLC检测方法改进研究

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

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。

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.