舒郁胶囊中麻黄碱的鉴别与含量测定研究

摘要

目的:建立舒郁胶囊中麻黄碱的鉴别和含量测定方法.方法:采用TLC法和HPLC法对舒郁胶囊中的麻黄碱进行定性鉴别和含量测定.色谱条件:色谱柱为Diamonsil C柱(250 mm×4.6 mm,5 μm),流动相为乙腈-0.02 mol·L磷酸二氢钾-磷酸(50:950:1),流速1.0 mL·min,检测波长207 nm,柱温40℃,进样量10μL.结果:在舒郁胶囊的TLC中检测到麻黄碱的特征斑点,舒郁胶囊中麻黄碱的平均含量为1.133 2 mg·g,麻黄碱在5.0～100.0 μg·mL范围内呈良好线性关系,r=0.999 96,平均回收率为98.96%,RSD=0.23%.结论:本方法简便可行,重现性好,可用于舒郁胶囊中麻黄碱的鉴别和含量测定.%Objective: To establish the method for identification and determination of ephedrine in Shuyu capsule. Methods: Ephedrine in Shuyu capsule was identified by TLC, and the content was determined by HPLC. A Diamonsil Cis column (250 mm × 4.6 mm, 5 μm) was used with a mobile phase consisting of acetonitrile-0.02 mol·L-1 potassium dihydrogen phosphate-phosphoric acid (50 ∶ 950 ∶ 1) at a flow rate of 1.0 mL·min-1, the detection wavelength was 207 nm and the column temperature was 40 ℃. The injection volume was 10 μL. Results: The characteristic spot of ephedrine was identified by TLC in Shuyu capsule. The average content of ephedrine in Shuyu capsule was 1.133 2 mg-g"; the calibration curve of ephedrine had a good linear relationship at the range of 5.0 μg·mL-1 to 100.0 μg·mL-1(r = 0. 999 96), and the average recovery was 98.96％ (RSD = 0.23％). Conclusion: This method is simple and repeatable. It can be used for identification and content determination of ephedrine in Shuyu capsule.