HPLC法测定三拗片中盐酸麻黄碱和盐酸伪麻黄碱的含量  

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

作　　者：董自波[1,2] 李超 

机构地区：[1]南京中医药大学,江苏南京210046 [2]江苏济川药业集团,江苏泰兴225400

出　　处：《西北药学杂志》2011年第5期329-330,共2页Northwest Pharmaceutical Journal

摘　　要：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phemomenexsynergiPolar-RP色谱柱（250mm×4．6mm，4μm）；以甲醇-0．9g·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：0．8mL·min^-1；检测波长：210nm；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。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.

关 键 词：高效液相色谱法 三拗片 盐酸麻黄碱 盐酸伪麻黄碱 

分 类 号：R927.2[医药卫生—药学]