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HPLC法测定富马酸卢帕他定的含量
引用本文:符传山. HPLC法测定富马酸卢帕他定的含量[J]. 中国热带医学, 2009, 9(7): 1352-1353
作者姓名:符传山
作者单位:海南华拓天涯制药有限公司,海南,海口,571159
摘    要:目的 建立HPLC法测定富马酸卢帕他定的含量。方法采用高效液相色谱法,以Diamonsil(钻石)C18柱(4.6×250mm,5μm)为色谱柱,pH-4.0磷酸盐缓冲液-甲醇(35:65)为流动相,流速1.0ml/min,检测波长244nm。结果富马酸卢帕他定在1.0012-100.12μg/ml范围内线性关系良好(r=0.9999),平均回收率为99.91%(RSD=0.58%)。结论所建立的方法准确、简便、快速,适用于富马酸卢帕他定的质量控制。

关 键 词:富马酸卢帕他定  HPLC  含量测定

Determination of rupatadine fumarate by HPLC
FU Chuan-shan. Determination of rupatadine fumarate by HPLC[J]. China Tropical Medicine, 2009, 9(7): 1352-1353
Authors:FU Chuan-shan
Affiliation:Hainan Huatuotianya Pharmaceutical Co.;Ltd.Haikou 571159;Hainan;P.R.China
Abstract:Objective To set up a HPLC method for determination of rupatadine fumarate. Methods A Diamonsil C18 column (4.6×250mm,5μm)was used with mobile phase of phosphate buffer (adjust pH to 4.0 with phosphoric acid)- methanol (35: 65) at a flow of 1.0 ml/min,the detection wavelength was 244nm. Results The standard curve showed a good hnearity in the range of 1.0012-100.12 g/ml. The average recovery was 99.91% with RSD was of 0.58%. Conclusion The method is accurate, feasible and rapid, and it is suitable for the quality control of rupatadine fumarate.
Keywords:Rupatadine fumarate  HPLC  Assay  
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