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HPLC法测定盐酸氨溴索缓释片的含量

Content determination of Ambroxol hydrochloride Sustained-Release Tablets by HPLC

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【作者】 庞燕军王欣曹春英张悫

【Author】 PANG Yanjun1,WANG Xin2,CAO Chunying2,ZHANG Que2(1.Institute for Food and Drug Control of Liaoning Province,Shenyang 110023,China;2.Shenyang Broadcast Television University,Shenyang 110003,China)

【机构】 辽宁省食品药品检验所沈阳广播电视大学

【摘要】 目的:建立高效液相法测定盐酸氨溴索缓释片含量的方法。方法:采用HypersilODS-2(4.6mm×150mm,5μm)色谱柱;流动相:乙腈-甲醇-0.01mol/L磷酸盐缓冲液(pH=3.0)(20:40:40);流速:1.0ml/min,检测波长:254nm。结果:盐酸氨溴索在0.244~4.880μg范围内与峰面积呈良好的线性关系(r=0.9996),平均回收率为99.70%,RSD=0.33%(n=9)。结论:本方法简便、灵敏、准确,可用于盐酸氨溴索缓释片的质量控制。

【Abstract】 Objective:To establish a method for the content determination of ambroxol hydrochloride in Ambroxol Hydrochloride Sustained-Release Tablets by HPLC.Methods:The Hypersil ODS-2(4.6 mm×150 mm,5 μm) column was used.The mobile phases consisted of acetonitrile,methanol and 0.01mol/L phosphoric acid(pH=3.0)(20:40:40),the flow rate was 1.0 ml/min and the detection wavelength was at 245 nm.Results:The linear ranges of Diphenhydramine Hydrochloride was at 0.244-4.880 μg(r=0.999 6),the average recovery was 99.70% with a RSD of 0.33%(n=9).Conclusion:The method is fast,reliable,accurate and can be used in the quality control of ambroxol hydrochloride in Ambroxol Hy-drochloride Sustained-Release Tablets.

  • 【文献出处】 中国医药导报 ,China Medical Herald , 编辑部邮箱 ,2009年33期
  • 【分类号】R927.2
  • 【被引频次】2
  • 【下载频次】122
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