高效液相色谱法测定止咳平喘类药中盐酸麻黄碱含量

Determination of Ephedrine Hydrochloride in Cough and Asthma Drugs by HPLC

目的建立测定止咳平喘类药中盐酸麻黄碱含量的高效液相色谱法。方法色谱柱为Edipse XDB-C18柱(150 mm×4.6 mm,5μm),流动相为乙睛-0.02 mol/L磷酸二氢钾溶液(用磷酸调pH至3.0)-0.2%三乙胺(5∶95∶0.1)。检测波长为206 nm,流速为1.0 mL/min,进样量为10μL,柱温为35℃。结果盐酸麻黄碱质量浓度在8.1~122.1μg/mL范围内与峰面积呈良好线性关系,r=1,平均回收率为100.22%,RSD=0.94%(n=9),最低检测限为2.1 ng。结论该方法简便,快速,准确,重现性好,可用于该类药的质量控制。

Objective To establish a high performance liquid chromatography（HPLC） method for the determination of ephedrine hy- drochloride in cough and asthma drugs. Methods The Edipse XDB-Cls column（150 ram^4. 6 ram,5 txm） was used. The mobile phase was acetonitrile-0.02 mol/L potassium dihydrogen phosphate solution （adjusting to pH 3.0 with phosphoric acid）-0. 2% triethylamine （5 ： 95 ： 0. 1 ）. The detection wavelength was at 206 nm. The flow - rate was 1.0 mL/min. The injection volume was 10 ~L and the column temperature was 35 ~C. Results The concentration of ephedrine hydrochloric showed a good linear in the range of 8.1 - 122.1 ug/mL. r= 1, the average recovery rate was 100. 22%, RSD =0.94% （n =9）, and the lowest detection limit was 2. 1 ng. Conclusion The method is simple, rapid, accurate and repeatable, which can be used to the quality control of these drugs.