HPLC法测定三拗片中盐酸麻黄碱和盐酸伪麻黄碱的含量

目的建立HPLC法测定三拗片中盐酸麻黄碱与盐酸伪麻黄碱总含量的方法。方法选用极性乙醚连接苯基键合硅胶为填充剂的phemomenex synergi Polar-RP色谱柱(250 mm×4.6 mm,4μm);以甲醇-0.9 g.L-1磷酸溶液(含体积分数0.04%三乙胺和体积分数0.02%二正丁胺)(1.5∶98.5)为流动相;流速:0.8 mL·min-1;检测波长:210 nm;进样量:5μL;柱温:30℃。结果盐酸麻黄碱在4.97~99.44μg.mL-1范围内线性关系良好,平均回收率为100.7%,RSD为0.5%(n=6);盐酸伪麻黄碱在2.01~60.30μg.mL-1范围内线性关系良好,平均回收率为101.9%,RSD为0.8%(n=6)。结论该方法简便、准确、重复性好,可作为三拗片的质量控制方法。

Determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in San'ao Tablets by HPLC

Objective To establish an HPLC method for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in San＇ao Tablets. Methods The samples were analyzed by a phemomenex synergi Polar-RP column （250 mm × 4.6 mm, 4 μm）, with mobile phase methanol-0.9 g· L^-1 phosphoric acid （0.04% triethylamine and 0.02% second butylamine） （1.5 ： 98.5） at flow rate 0.8 mL · min^-1 and detection at UV wavelength of 210 nm. Results The linear range of ephedrine hydrochloride was 4.97- 99.44μg · mL^-1 and the average recovery was 100.7 % （ n = 6 ） with RSD 0.5% ;The linear range of pseudoephedrine hydrochlo- ride was 2.01-60.30 μg ·mL^-1 and the average recovery was 101.9% （ n =6） ,with RSD 0.8%. Conclusion This method is simple,accurate, reproducible, and can be used as a quality control method of San＇ao Tablets.