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高效液相色谱法测定富马酸氯马斯汀片的溶出度
引用本文:王金龙,姜建国. 高效液相色谱法测定富马酸氯马斯汀片的溶出度[J]. 中国药业, 2007, 16(23): 8-9
作者姓名:王金龙  姜建国
作者单位:河北省药品检验所,河北,石家庄,050011
摘    要:目的建立高效液相色谱法测定富马酸氯马斯汀片的溶出度。方法以0.1mol/L盐酸为溶出介质,转速为75r/min,色谱柱为C18柱(150mm×4,6mm,5μm),流动相为甲醇-0.01mol/mL磷酸二氢钾-三乙胺(70:29:1,用磷酸调节pH值为5.0),检测波长为220nm。结果富马酸氯马斯汀片的质量浓度在1,315~0,1578μg/mL范围内与峰面积线性关系良好,r=0.9994,平均回收率为99.29%。RSD为0,51%(n=6)。结论该法简便、准确,重现性好,能有效控制富马酸氯马斯汀片的溶出度。

关 键 词:富马酸氯马斯汀片  溶出度  高效液相色谱法
文章编号:1006-4931(2007)23-0008-02
修稿时间:2007-05-23

Determination of Dissolution of Clemastine Fumarate Tablet by HPLC
Wang Jinlong,Jiang Jianguo. Determination of Dissolution of Clemastine Fumarate Tablet by HPLC[J]. China Pharmaceuticals, 2007, 16(23): 8-9
Authors:Wang Jinlong  Jiang Jianguo
Affiliation:Wang Jinlong, Jiang Jianguo ( Hebei Provincial Institute for Drug Control, Shijiazhuang, Hebei, China 050011)
Abstract:Objective To establish a method of dissolution of clemastine fumarate tablet by HPLC method. Methods 0. 1 mol/L HCI was used as dissolution medium and the rotational speed was 75 r/min. A HPLC method was used. Using Cis column (150 mm×4.6 mm,5μm), the mobile phase was methanol-0.01 mol/L potassium dihydrogen phosphate-triethylaminum (70:29:1, pH 5.0 adjusted by phospho- ricacid) .The detection wavelength was 220 nm. Results There was linear relationship within the range of 1. 315-0. 157 8 μg/mL, r= 0. 999 4. The average recovery rate was 99. 51%. The RSD of the method was 0. 51% (n =6). Conclusion The method is simple,accurate and reproducible. It can be used for the quality control of dissolution of Clemastinc Fumarate Tablet.
Keywords:clemastine fumarate tablet  dissolution  HPLC
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