超高效液相色谱-串联质谱法测定中成药中非法添加枸橼酸西地那非的研究

Determination of sildenafil citrate illegally mixed into traditional Chinese medicinal preparation by ultra performance liquid chromatography-tandem mass spectrometry

目的:建立快速、准确、高灵敏度的中成药中非法添加枸橼酸西地那非的专属性检测方法。方法:采用超高效液相色谱-串联质谱联用法,离子源为ESI源,正、负离子同时检测,通过相对分子质量、二级质谱碎片信息、液相色谱保留时间3方面信息,对中药中非法添加的枸橼酸西地那非进行测定。结果:3种受试制剂中2种检测到掺有枸橼酸西地那非,1种未检测到。结论:此方法选择性强、灵敏度高,可作为分析中成药中非法添加枸橼酸西地那非的有效检测方法。

AIM： To establish a quick, accurate, sensitive method for analysing sildenafil citrate illegally added into traditional Chinese medicinal preparation. METHODS： The ultra performance liquid chromatography-quadrupole mass spectrometry method was used. Electrospay ionization （ESI） source was applied and operated in the positive and negative ion mode. The compound of sildenafil citrate illegally added into traditional Chinese medicinal preparations were identified according to the spectrum, chromatographic behavior and mass spectral data by comparison with those of reference substance. RESULTS ： Sildenafil citrate was found in two formnulations of three. CONCLUSION： The method is selective and sensitive and can be used to detect the sildenafil citrate illegally added into traditional Chinese medicinal preparations.