HPLC法测定咳特灵糖浆中马来酸氯苯那敏的含量及含量均匀度

Determination of Content and Content Uniformity of ChlorPhenamine maleate in Suganning Capsules by HPLC

目的:建立用HPLC法测定咳特灵糖浆中马来酸氯苯那敏的含量及含量均匀度的方法。方法:色谱柱为Kromasil柱C18(4.6×250mm,5μm);流动相为乙腈-0.35%磷酸-0.35%三乙胺溶液(11∶89),流速为1.0ml/min,检测波长为264nm,进样量为10μl;柱温为室温。结果:以对照品进样浓度为横坐标(X),峰积积分值为纵坐标(Y)绘制标准曲线,回归方程为:Y=5973.6X-3462.8,相关系数r=0.9992。线性范围为在20.0～70.0μg/ml。结论:该方法简便、准确,可用于咳特灵糖浆中的马来酸氯苯那敏的质量控制。

Objective： To establish method for determining the content and uniformity of ChlorPhenamine maleate in Keteling syrup by HPLC. Methods： The Kromasil -C18 （4. 6×250mm, 5μm） was used and mobile phase was acetonitrile -0. 35% Phosphoric acid-0. 35% triethylamine （11： 89）, and its temperature was used at room temperature, with the flow rate of 1.0ml/min and the wavelength of detection of 262 nm, and the injection amount of 10μ1. Results： Chlorphenamine maleat showed a good linear relation- ship in the range of 20. 0 -70. 0μg/ml, Y = 1.06×105X ＋29014. 3, r =0. 9995. Conclusions： The method is simple, accurate, and can be used to determine the content assaying of ChlorPhenamine maleate in Keteling syrup.