今日药学

2009, v.19(03) 19-22

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对复方感冒灵胶囊中马来酸氯苯那敏的含量测定
Determination of Chlorphenamine Maleate in Compound Ganmaoling Capsules by HPLC

曹艳芳,黄夏敏,冯倩玲,邓海玲,简柳清
CAO Yan-fang1,HUANG Xia-min2,FENG Qian-ling2,DENG Hai-ling2,JIAN Liu-Qing2(Guangzhou Qixing Pharmaceutical Co.

摘要(Abstract):

目的建立高效液相色谱(HPLC)法测定复方感冒灵胶囊中马来酸氯苯那敏的含量及含量均匀度。方法采用HPLC法,色谱柱为HypersilODS2(5μm×4.6mm×200mm);流动相为乙腈-1%冰醋酸;流速1.0ml/min;检测波长262nm。结果马来酸氯苯那敏在0.010152~0.101520mg/ml范围内呈良好线性关系,r=0.9996;平均回收率为103.51%,相对标准偏差值(RSD)=1.76%。结论该方法可准确地进行复方感冒灵胶囊中马来酸氯苯那敏的含量测定及含量均匀度检查,可用于该制剂的质量控制。
Objective To establish the HPLC method for the determination and content uniformity of chlorphenamine maleate in Ccompound ganmaoling Ganmaoling capsules.Methods HPLC was performed on Hypersil ODS2 (5 μm×4.6mm×200 mm).The mobile phase was acetonitrile-1% acetic acid.The detection wavelength was 262 nm,and the flow rate was 1.0 ml /min.Results Chlorphenamine maleate showed a good linearity in the range of 0.010152~0.101520 mg /ml,r=0.9996.The average recovery was 103.51%,and RSD was 1.76%.Conclusion This method is effective,and can be used for the quality control of chlorphenamine maleate in Compound compound ganmaoling capsules.

关键词(KeyWords): 复方感冒灵胶囊;马来酸氯苯那敏;高效液相色谱法;含量及含量均匀度
Compound compound ganmaoling capsules;Chlorphenamine chlorphenamine maleate;HPLC;determination;content uniformity

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作者(Author): 曹艳芳,黄夏敏,冯倩玲,邓海玲,简柳清
CAO Yan-fang1,HUANG Xia-min2,FENG Qian-ling2,DENG Hai-ling2,JIAN Liu-Qing2(Guangzhou Qixing Pharmaceutical Co.

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