HPLC法测定小儿咳喘灵口服液中盐酸麻黄碱和盐酸伪麻黄碱含量
Simultaneous Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Xiaoer Kechuanling Oral Liquid by HPLC
毕福钧 1林彤1
作者信息
- 1. 广州市药品检验所,广东广州510160
- 折叠
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,5μm),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.
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.
关键词
小儿咳喘灵口服液/盐酸麻黄碱/盐酸伪麻黄碱/高效液相色谱法Key words
Xiaoer Kechuanling Oral Liquid/Ephedrine Hydrochloride/Pseudoephedrine Hydrochloride/HPLC引用本文复制引用
出版年
2014
国家科技期刊平台
NSTL
维普
万方数据