麻杏抗感颗粒质量控制方法考察

Quality Control of Maxin g Kan ggan Granules

目的完善麻杏抗感颗粒的质量控制方法。方法采用HPLC法,色谱柱为Wondasil C18(250 mm×4.6mm,5μm);流动相为乙腈-0.05mol·L^(-1)磷酸二氢钾溶液(用磷酸调至pH 3.0)(5∶95);流速:1.0 ml·min^(-1);检测波长:0~17min,245nm[(R,S)-告依春];17~30min,210nm(盐酸麻黄碱、盐酸伪麻黄碱);柱温:30℃;进样量:10μl。结果样品色谱图中显示与对照品色谱图中相同的3个色谱峰。盐酸麻黄碱和盐酸伪麻黄碱检测质量浓度线性范围分别为4.88~48.77μg·ml^(-1)(r=0.999 9)、1.85~18.50μg·ml^(-1)(r=0.999 9);加样回收率分别为96.32%~100.21%(RSD为1.49%,n=9)、96.23%~99.73%(RSD为1.20%,n=9)。结论该方法简便、快速、准确,能更全面有效控制麻杏抗感颗粒的质量。

Objective To improve the method of quality control of Maxing Kanggan granules.Methods HPLC was performed on a Wondasil C18 column（250 mm×4.6 mm,5μm）with the mobile phase composed of acetonitrile-0.05 mol·L^（-1） potassium phosphate monobasic solution（pH adjusted to 3.0 with phosphoric acid）（5∶95）at a flow rate of 1.0 ml·min-1.The detection wavelength was set at 245 nm for（R,S）-goitrin in 0-17 min,210 nm for ephedrine hydrochloride and pseudoephedrine hydrochloride in17-30 min.The column temperature was 30℃and injection volume was 10μl.Results The chromatogram of the samples showed three peaks which were similar to the reference.The linear ranges of ephedrine hydrochloride and pseudoephedrine hydrochloride were 4.88-48.77μg·ml^（-1）（r =0.999 9）and 1.85-18.50μg·ml^（-1）（r =0.9999）,respectively.The recoveries were 96.32%-100.21%（RSD=1.49%,n =9）and 96.23%-99.73%（RSD=1.02%,n=9）,respectively.Conclusion This method is simple,quick,accurate and can be used for effective control the quality of Maxing Kanggangranules.