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目的:研究高效液相色谱法测定中药制剂中西地那非和他达那非的含量。方法:使用高效液相色谱法对中药制药中西地那非和他达那非的含量进行测定。结果:西地那非回归方程:A=1.2541e+007C-8.5263e+0.04(r=0.9999);他达拉非回归方程:A=8.7635e+006C-8.0756e+0.04(r=0.9999)。西地那非的峰面积相对标准偏差RSD为0.91%,平均回收率为98.33%,相对标准偏差RSD为0.57%(n=6);他达那非的峰面积相对标准偏差RSD为0.95%,平均回收率为98.44%,相对标准偏差RSD为0.49%(n=6)。结论:使用高效液相色谱法可以对非法在中药制剂中掺入西地那非和他达那非的含量进行有效测量,对于中药制剂市场的整顿和监督有重要意义。
Objective: To study the HPLC method for the determination of sildenafil and tadalafil in traditional Chinese medicine preparations. Methods: HPLC was used to determine the contents of cina sildenafil and tadalafil in Chinese medicine. Results: The sildenafil regression equation: A = 1.2541e + 007C-8.5263e + 0.04 (r = 0.9999); Tadalafil regression equation: A = 8.7635e + 006C-8.0756e + 0.04 (r = 0.9999). The relative standard deviations (RSDs) of sildenafil were 0.91%, the average recoveries were 98.33% and the relative standard deviations (RSDs) were 0.57% (n = 6). The relative standard deviations of tadalafil RSD were 0.95% The average recovery was 98.44% and the relative standard deviation (RSD) was 0.49% (n = 6). Conclusion: The effective measurement of the content of sildenafil and tadalafil which is illegally incorporated into traditional Chinese medicine preparations can be effectively measured by HPLC, which is of great significance for the rectification and supervision of the market of traditional Chinese medicine preparations.