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HPLC法测定三拗片中盐酸麻黄碱和盐酸伪麻黄碱的含量

Determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in San’ao Tablets by HPLC

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【作者】 董自波李超

【Author】 DONG Zibo1,2,LI Chao2*(1.Nanjing University of Traditional Chinese Medicine,Jiangsu Nanjing,210046;2.Jiangsu Jumpcan Medicines Co.Ltd.,Jiangsu Taixing 225400,China)

【机构】 南京中医药大学江苏济川药业集团

【摘要】 目的建立HPLC法测定三拗片中盐酸麻黄碱与盐酸伪麻黄碱总含量的方法。方法选用极性乙醚连接苯基键合硅胶为填充剂的phemomenex synergi Polar-RP色谱柱(250 mm×4.6 mm,4μm);以甲醇-0.9 g.L-1磷酸溶液(含体积分数0.04%三乙胺和体积分数0.02%二正丁胺)(1.5∶98.5)为流动相;流速:0.8 mL·min-1;检测波长:210 nm;进样量:5μL;柱温:30℃。结果盐酸麻黄碱在4.97~99.44μg.mL-1范围内线性关系良好,平均回收率为100.7%,RSD为0.5%(n=6);盐酸伪麻黄碱在2.01~60.30μg.mL-1范围内线性关系良好,平均回收率为101.9%,RSD为0.8%(n=6)。结论该方法简便、准确、重复性好,可作为三拗片的质量控制方法。

【Abstract】 Objective To establish an HPLC method for determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in San’ao Tablets.Methods The samples were analyzed by a phemomenex synergi Polar-RP column(250 mm×4.6 mm,4 μm),with mobile phase methanol-0.9 g·L-1phosphoric acid(0.04% triethylamine and 0.02% second butylamine)(1.5∶98.5) at flow rate 0.8 mL·min-1 and detection at UV wavelength of 210 nm.Results The linear range of ephedrine hydrochloride was 4.97-99.44 μg·mL-1 and the average recovery was 100.7%(n=6) with RSD 0.5%;The linear range of pseudoephedrine hydrochloride was 2.01-60.30 μg·mL-1 and the average recovery was 101.9%(n=6),with RSD 0.8%.Conclusion This method is simple,accurate,reproducible,and can be used as a quality control method of San’ao Tablets.

  • 【文献出处】 西北药学杂志 ,Northwest Pharmaceutical Journal , 编辑部邮箱 ,2011年05期
  • 【分类号】R927.2
  • 【被引频次】9
  • 【下载频次】220
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