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HPLC法测定清肺消炎丸中盐酸麻黄碱的含量
引用本文:罗辉,王原,李昂,闫晓楠.HPLC法测定清肺消炎丸中盐酸麻黄碱的含量[J].世界科学技术,2009,11(3):461-464.
作者姓名:罗辉  王原  李昂  闫晓楠
作者单位:罗辉,李昂(天津中新药业集团股份有限公司达仁堂制药厂,天津,300457);王原,闫晓楠(天津中新药业研究中心,天津,300457) 
摘    要:目的:建立HPLC法测定清肺消炎丸中盐酸麻黄碱含量的方法。方法:色谱柱:Phenomenex GEMINI C18(5μm,4.6mm×250mm);流动相:乙腈-0.02mol·L^-1磷酸二氢钾溶液(磷酸调pH值至2.7)(4:96);检测波长:207nm;柱温:30℃;流速:1.0mL·min^-1。结果:线性范围为0.0416~0.6656μg(r=0.9999),平均回收率为99.71%,RSD为0.75%,重复性RSD为1.12%(n=6),精密度RSD为1.27%(n=6),稳定性RSD为0.80%。结论:本文所得方法稳定、可靠,可作为该制剂的质量控制方法。

关 键 词:清肺消炎丸  盐酸麻黄碱  HPLC

HPLC Determination of Ephedrine Hydrochloride Content in Qingfei Xiaoyan Pill
Affiliation:Luo Hui, Wang Yuan, Li Ang, Yan Xiaonan (1.Darentang Pharmacy, Zhongxin Pharmaceuticals, Tianjin 300457, China; 2. R&D Center, Zhongxin Pharmaceuticals, Tianjin 300457, China)
Abstract:Authors established an HPLC method to determine Ephedrine hydrochloride content in Qingfei Xiaoyan Pill. In the study, Ephedrine hydrochloridein were assayed on a Phenomenex GEMINI C18(5μm, 4.6mm×250mm)column, with the mobile phase composed of Acetonitrile-0.02mol·L^-1 KH2PO3 solution (adjusted to PH=2.7 with phosphoric acid) (4: 96) at a flow rate of 1.0 ml·min^-1. The determination wavelength was defined at 207 nm. Results show linear calibration curves were ranged from 0.0416μg to 0.6656μg (r = 0.9999)for Ephedrine hydrochloridein. The averaged recovery (n=6) of Ephedrine hydrochloridein was 99.71% (RSD=0.75%). The method has been proved simple, reliable, accurate, and repeatable, and is effective for the quality control of Qingfei Xiaoyan Pill.
Keywords:HPLC
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