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目的建立小儿咳喘灵口服液中盐酸麻黄碱和盐酸伪麻黄碱的含量测定方法。方法采用高效液相色谱(HPLC)法,色谱柱Kromasil(250 mm伊4.6 mm,5滋m),流动相为甲醇-0.01 mol·L-1磷酸二氢钾溶液(11颐89,磷酸调pH值至2.3),流速:1.0 mL·min-1,检测波长:210 nm。结果盐酸麻黄碱在0.0048耀0.2413滋g(r=1.0000)、盐酸伪麻黄碱在0.0030耀0.1524滋g(r=1.0000)的范围内均呈良好的线性关系,平均回收率分别为97.7%和98.5%(n=6)。结论该方法简便、准确,具有良好的重复性和稳定性,可同时测定盐酸麻黄碱和盐酸伪麻黄碱的含量,可作为小儿咳喘灵口服液质量控制的方法。
Objective To establish a method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Xiaoerkechuanling Oral Liquid. Methods The mobile phase was Kromasil (250 mm × 4.6 mm, 5 μm) with a mobile phase of methanol-0.01 mol·L-1 potassium dihydrogen phosphate (pH = 11, pH = Value to 2.3), flow rate: 1.0 mL · min-1, detection wavelength: 210 nm. Results Ephedrine hydrochloride showed a good linear relationship at the dosages of 0.2413 g / (g) 0.0048, 0.0084 g / (r = 1.0000) and the average recoveries were 97.7% and 98.5% respectively n = 6). Conclusion The method is simple, accurate, and has good repeatability and stability. It can simultaneously determine the content of ephedrine hydrochloride and pseudoephedrine hydrochloride, and can be used as the quality control method of Xiaoerkechuanling oral liquid.