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高效液相色谱法测定多非利特胶囊的溶出度
引用本文:程佩素.高效液相色谱法测定多非利特胶囊的溶出度[J].中国药房,2006,17(23):1822-1823.
作者姓名:程佩素
作者单位:浙江温岭市第一人民医院药剂科,温岭市,317500
摘    要: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。

关 键 词:多非利特  高效液相色谱法  溶出度
文章编号:1001-0408(2006)23-1822-02
收稿时间:10 24 2006 12:00AM
修稿时间:11 6 2006 12:00AM

Determination of the Dissolution of Dofetilide Capsules by HPLC
CHENG Peisu.Determination of the Dissolution of Dofetilide Capsules by HPLC[J].China Pharmacy,2006,17(23):1822-1823.
Authors:CHENG Peisu
Abstract:OBJECTIVE:To establish a HPLC method for the determination of the dissolution of dofetilide capsules.METHODS:The separation was performed on Diamonsil-C 18 column,with mobile phase consisted of water-methanol(56∶44,with pH adjusted to 3.4with 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=0.9999,n=7),the average recovery was97.55%(RSD=0.14%),the mean dissolutions at45minute of the 3 batches of samples were all above 90%.CONCLUSION:The method is simple,rapid and accurate.
Keywords:Dofetilide  HPLC  Dissolution
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