高效液相色谱法测定多非利特胶囊的溶出度

Determination of the Dissolution of Dofetilide Capsules by HPLC

目的:建立以高效液相色谱法测定多非利特胶囊溶出度的方法。方法:色谱柱为DiamonsilC18,流动相为水-甲醇(56∶44,用冰醋酸调pH至3.4),检测波长为229nm。按峰面积外标法计算浓度,并以小杯法测定溶出度。结果:多非利特浓度在1～51μg/ml范围内线性关系良好(r=0.9999,n=7),加样回收率为97.55%(RSD=0.14%),3批样品45min平均溶出度均在90%以上。结论:本方法操作简便、快捷,结果准确。

OBJECTIVE： To establish a HPLC method for the determination of the dissolution of dofetilide capsules METHODS： The separation was performed on Diamonsil-C18 column, with mobile phase consisted of water- methanol （56 ： 44,with pH adjusted to 3.4 with glacial acetic acid） at a wavelength of 229nm. The concentration was computed using external reference method of peak area and the dissolution was determined by small cup method. RESULTS： The method showed a good linear relationship in the range of 1μg/ml-51μg/ml（r = 0.9 999, n = 7）, the average recovery was 97,55% （RSD = 0.14%）, the mean dissolutions at 45 minute of the 3 batches of samples were all above 90%. CONCLUSION ： The method is simple, rapid and accurate.