[关键词]
[摘要]
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 × 4.6 mm,5 μm),流动相为甲醇-0.01 mol·L-1磷酸二氢钾溶液(11 ∶ 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 0.0048~0.2413 μg(r = 1.0000)、盐酸伪麻黄碱在0.0030~0.1524 μg(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。
[Key word]
[Abstract]
Objective To develop a method for the simultaneous determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Xiaoer Kechuanling Oral Liquid. Methods HPLC was adopted. The analysis was performed on a Kromasil C18 column(250×4.6 mm,5 μm) with the mobile phase consisting of methanol -0.01 mol·L-1 potassium dihydrogen phosphate(11∶89) at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 210 nm. Results The linear range of ephedrine hydrochloride was 0.0048~0.2413 μg(r=1.0000)and that of pseudoephedrine hydrochloride was 0.0030~0.1524 μg(r=1.0000),and the average recovery(n=6) was 97.7 % and 98.5 %,respectively. Conclusion The developed method is rapid,accurate and with good repeatability. It is suitable for the quantitative analysis of ephedrine hydrochloride and pseudoephedrine hydrochloride in Xiaoer Kechuanling Oral Liquid.
[中图分类号]
R284.1
[基金项目]