HPLC法测定双黄通痹颗粒中麻黄碱、伪麻黄碱的含量

Determination of ephedrine and pseudoephedrine in Shuanghuangtongbi granula by HPLC

目的建立复方制剂双黄通痹颗粒中麻黄碱、伪麻黄碱的含量测定方法。方法色谱柱为Akasil C18(4.6 mm×250 mm,5μm);流动相为0.02 mol/L磷酸二氢钾(含0.3%二乙胺,磷酸调pH=3)-乙腈(体积比96∶4);检测波长为210 nm;流速为1.0mL/min;柱温为40℃;进样体积为10μL。结果麻黄碱在25.2～504μg/mL范围内呈良好线性关系,平均回收率为101.23%;伪麻黄碱在17.6～352μg/mL范围内呈良好线性关系,平均回收率为99.25%。结论本测定方法简便可行、重复性好,可用于双黄通痹颗粒中有效成分麻黄碱、伪麻黄碱的含量测定。

Objective To determine the contents of ephedrine and pseudoephedrine in Shuanghuangtongbi granula.Methods HPLC was used to determine the content of ephedrine and pseudoephedrine in Shuanghuangtongbi granula.Samples were analyzed on an Akasil C18 column（4.6 mm×250 mm,5 μm）.The mobile phase consisted of 0.02 mol/L potassium dihydrogen phosphate（0.3% diethylamine,phosphoric acid accommodate pH3）-acetonitrile（96：4）.The column temperature was 40 ℃ and flow rare 1.0 ml/min at a detection wavelength of 210 nm.Results A good linearity was obtained over 25.2-504 μg/mL of ephedrine and 17.6-352 μg/mL of pseudoephedrine for plasma with a good correlation coefficient.The average recoveries of ephedrine and pseudoephedrine were 101.23%and 99.25%,respectively.Conclusion This method is simpleand quick.Which could be used for the quality control of Shuanghuangtongbi granula.