高效液相色谱法测定麻杏口服液中盐酸麻黄碱及盐酸伪麻黄碱的含量
投稿时间:2014-10-13  修订日期:2015-01-13  点此下载全文
引用本文:张敏新,黄爱文,宋洪涛.高效液相色谱法测定麻杏口服液中盐酸麻黄碱及盐酸伪麻黄碱的含量[J].药学实践杂志,2015,33(5):445~447
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作者单位E-mail
张敏新 南京军区福州总医院药学科, 福建 福州 350025  
黄爱文 南京军区福州总医院药学科, 福建 福州 350025  
宋洪涛 南京军区福州总医院药学科, 福建 福州 350025 sohoto@vip.163.com 
基金项目:军队医疗机构制剂标准提高科研专项重点课题(13ZJ01)
中文摘要:目的 建立HPLC法测定麻杏口服液中盐酸麻黄碱及盐酸伪麻黄碱的含量。 方法 采用Phenomenex Hydro-RP (250 mm×4.6 mm,4 μm)色谱柱,以乙腈(A)-0.1%磷酸溶液(含0.1%三乙胺)(B)为流动相,梯度洗脱(0~20 min,3%→10% A),流速:1.0 ml/min,检测波长:210 nm,进样量:20 μl。 结果 盐酸麻黄碱在0.99~39.6 μg/ml范围内线性关系良好,r=0.999 9, 平均回收率为101.5%,RSD为1.77%(n=6);盐酸伪麻黄碱在1.09~43.6 μg/ml范围内线性关系良好,r= 0.999 9,平均回收率为100.8%, RSD为 1.96%(n=6)。 结论 本法简便、可靠、准确,可用于该制剂的质量控制。
中文关键词:麻杏口服液  盐酸麻黄碱  盐酸伪麻黄碱  高效液相色谱法
 
Simultaneous determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Maxing oral solution by HPLC
Abstract:Objective To establish an HPLC method for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Maxing oral solution. Methods Phenomenex Hydro-RP (250 mm×4.6 mm, 4 μm) was adopted. Acetonitnile (A) and 0.1% phosphonic acid solution (0.1% triethanolamine solution)(B) was used as gradient mobile phase(0-20 min, 3%→10% A)at flow rate was 1.0 ml/min and the program of UV gradient absorbance detection was 210 nm. The sample volume was 20 μl. Results A good linearity was obtained over the concentration range of 0.99-39.6 μg/ml for ephedrine hydrochloride (r=0.999 9) and 1.09-43.6 μg/ml for pseudoephedrine hydrochloride (r=0.999 9). The average recovery of ephedrine hydrochloride was 101.5% with RSD of 1.77% (n=6), and the average recovery of pseudoephedrine hydrochloride was 100.8% with RSD of 1.96% (n=6). Conclusion This method was simple,accurate and quick,which could be used for determination and quality control of Maxing oral solution with good selectivity and repeatability.
keywords:Maxing oral solution  ephedrine hydrochloride  pseudoephedrine hydrochloride  HPLC
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