HPLC同时测定防风通圣丸中盐酸麻黄碱和盐酸伪麻黄碱的含量

Simultaneous determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Fangfeng Tongsheng pills by HPLC

目的:建立同时测定防风通圣丸中盐酸麻黄碱和盐酸伪麻黄碱含量的高效液相色谱方法。方法:以超声水提取的方法处理样品,采用Agilent Eclipse XDB C18色谱柱(4.6 mm×150 mm,5μm),以乙腈^(-1).5%十二烷基硫酸钠(63∶27)为流动相,流速1.0 m L·min^(-1),检测波长210 nm,柱温25℃,进样量10μL,运行时间22 min。结果:盐酸麻黄碱和盐酸伪麻黄碱线性范围分别为2.15~43.0μg·m L^(-1)(r=0.999 9)和1.98~39.6μg·m L^(-1)(r=0.999 9);回收率(n=6)分别为100.3%(RSD=1.9%)、99.8%(RSD=2.0%)。防风通圣丸中盐酸麻黄碱和盐酸伪麻黄碱含量分别为448.6μg·g^(-1)和208.1μg·g^(-1)。结论:该方法经方法学验证,能够用于防风通圣丸中盐酸麻黄碱和盐酸伪麻黄碱的含量测定,可为标准改进提供参考。

Objective： To develop an HPLC method for simultaneous quantitation of ephedrine hydrochloride and pseudoephedrine hydrochloride in Fangfeng Tongsheng pills. Methods： Samples were extracted with water ultrasonic and analyzed on an Agilent Eclipse XDB-C18 （ 4.6 mm × 150 mm, 5 μ m）. The mobile phase consisted of acetonitrile and 1.5% dodecyl sodium sulfate （ 63 ： 27）. The flow rate was 1.0 mE·min^-1, the detection wavelength was set at 210 nm, the column temperature was controlled at 25 ℃, the injection volume was 10 · L, and the running time was 21.5 min. Results： The linear ranges of ephedrine hydroehloride and pseudoephedrine hydrochloride were 2.15-43.0 μg· mL^-1 （ r=0.999 9 ） and 1.98-39.6 μ g· mL^-1 （ r=0.999 9 ）, respectively. The average recoveries （ n=6 ）were 100.3% （ RSD=l.9% ） and 99.8% （ RSD=2.0% ）, respectively. The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were 448.6 μ g· g^-1 and 208.1 μ g· g^-l, respectively. Conclusion： Through the methodology validation, the established method is suitable for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Fangfeng Tongsheng pills, which provides a reference for standard improvement.