同时检查中成药中添加枸橼酸西地那非或他达拉非的方法研究

Method for simultaneous determination of sildennafil citrate and tadalafei added illegally in traditional Chinese medicine preparation

目的:建立同时检查中成药中添加枸橼酸西地那非或他达拉非的方法。方法:分别采用薄层色谱、高效液相法及高效液相色谱-二极管阵列检测器光谱法以确定是否添加枸橼酸西地那非或他达拉非。结果:薄层色谱中枸橼酸西地那非和他达拉非的斑点分离效果好,斑点清晰、重现性好;高效液相色谱中西地那非和他达拉非分离效果良好,出峰时间合适;二极管阵列检测光谱法对西地那非和他达拉非的紫外吸收光谱进一步确定薄层色谱与高效液相色谱检查结果。采用本文所建立的方法检测出2批中成药中含有他达拉非。结论:所建立的方法简单、可靠,重现性好,可用于同时检查中成药中是否非法添加枸橼酸西地那非或他达拉非。

Objective：To establish the methods for simultaneous determination of sildennafil citrate or tadalafei added illegally in traditional Chinese medicine preparations. Methods： TLC, HPLC and HPLC - diode - array - detector methods were established to determinate the sildennafil citrate and tadalafeio Results：The spots of samples on TLC can be well separated and the spots were clear and reproducible;while high separation efficiency and reasonable retention time were achieved by HPLC method. And the result of HPLC - diode - array - detector methods will prove the result of TLC and HPLC method. The established methods help us successfully determinate the tadalafei added illegal added in two samples. Conclusion：The method is simple and rapid and can be used to for simultaneous determination of sildennafil citrate or tadalafei added illegally in traditional Chinese preparation.