高效液相色谱法测定复方甘草麻黄碱片中盐酸麻黄碱含量

Determination of Content of Ephedrine Hydrochloride in Compound Glycyrrhiza Ephedrine Tablets by RP-HPLC

目的建立测定复方甘草麻黄碱片中麻黄碱含量的方法。方法采用反相高效液相色谱法,色谱柱为Diamonsil（钻石）C18柱（250 mm×4.6 mm,5μm）,流动相为0.1 mol/L磷酸二氢钾溶液-甲醇（75∶25）,流速1.0 mL/min,检测波长210 nm。结果盐酸麻黄碱质量浓度在1.06～21.1μg/mL范围内与峰面积呈良好的线性关系（r^2=0.999 9）,最低检测限为1.06 ng/mL。平均回收率分别为100.54%,99.86%,100.20%;RSD为0.90%,0.37%,0.43%（n=9）。结论该方法专属性好,准确、灵敏,用于测定复方甘草麻黄碱片中麻黄碱的含量,结果可靠。

Objective To establish a RP-HPLC method for determining the ephedrine hydrochloride content in Compound Glycyrrhiza Ephedrine Tablets. Methods The RP-HPLC method was adopted with the Diamonsil C18 Column（ 250 mm × 4. 6 mm, 5 μm） and the0. 1 mol / L potassium dihydrogen phosphate solution-methanol（ 75 ∶ 25） as the mobile phase at the flow rate of 1. 0 mL / min. The detection wavelength was 210 nm. Results The linear range of ephedrine hydrochloride was 1. 06- 21. 1 μg / mL（ r^2= 0. 999 9）,with the lowest limit of the detection 1. 06 ng / mL; the average recovery rate of high, middle and low concentrations were 100. 54%, 99. 86%,100. 20%（ RSD = 0. 90%, 0. 37%, 0. 43%） respectively. Conclusion This method is more specific, accurate, sensitive and reliable for the determination of the ephedrine hydrochloride content in Compound Glycyrrhiza Ephedrine Tablets.