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薄层色谱法测定阿德福韦酯有关物质

TLC in the Determination of Related Substances in Adefovir Dipivoxil

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【作者】 施亚琴魏玲许鸣镝俞如英杨腊虎

【Author】 SHI Ya - qin, WEI Ling, XU Ming - di, YU Ru - ying and YANG la - hu(National Institute for the Control of Pharmaceutical and Biological Products of China, Beijing 100050)

【机构】 中国药品生物制品检定所

【摘要】 目的:建立阿德福韦酯有关物质薄层色谱检查法。方法:反相薄层色谱法,甲醇-水(3:1)为展开剂,在紫外光254nm 下检视。结果:经方法学验证本法能有效分离并检测阿德福韦酯中的有关物质。最小检测限为0.1μg。结论:反相薄层色谱法避免了阿德福韦酯在硅胶薄层色谱法中发生分解的现象,且分离效果好,检测灵敏度高。

【Abstract】 Objective: To establish a TLC method for the determination of the related substances in adefovir dipiv-oxil. Methods: Reverse phase thin - layer chromatography, using a mixture of methanol and water (3:1) , detecting at 254 nm. Results: The resolution was good between the drug and its related substances. The minimum detection limit was 0. 1 μg(0. 1% ). Conclusion:This method was effective with high detection sensitivity. Moreover it could avoid hydrolytic degradation of adefovir dipivoxil promoted by silica gel on normal - phase TLC method.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2004年06期
  • 【分类号】R927
  • 【被引频次】10
  • 【下载频次】416
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