摘要
Abstract
Objective To establish an ultra-high-performance liquid chromatography-mass spectrometry(UPLC-MS/MS)method for detecting antifungal drugs in external preparations of traditional Chinese medicine(TCM).Methods Sixteen types of TCM cream preparations provided by the Shandong Center for Disease Control and Prevention were used as the testing objects.The chromatographic column was an Agilent Poroshell SB-C18 column(100 mm×2.1 mm,2.7 µm),the mobile phase was 0.1%formic acid aqueous solution-acetonitrile(containing 0.1%formic acid aqueous solution)with gradient elution,the flow rate was 0.3 mL/min,the column temperature was 30℃,and the injection volume was 2 µL.Electrospray ionization was adopted with positive ion,multi-reaction monitoring mode,the ion source temperature was 250℃,the capillary voltage was 3.5 kV,the desolvation gas temperature was 325℃.Results The linear ranges of griseofulvin,ketoconazole,clotrimazole,econazole nitrate,miconazole nitrate,fluconazole,bifonazole,flucytosine,and naftifine hydrochloride were in the range of 1-20 ng/mL,10-200 ng/mL,0.5-10ng/mL,0.5-10ng/mL,0.5-10ng/mL,1-20ng/mL,1-20ng/mL,5-100ng/mL,0.5-10ng/mL,respectively(r≥0.995,n=6).The RSDs of precision,stability and repeatability tests were all lower than 5.0%.The average recovery rates were in the range of 83.14%to 102.01%with RSDs in the range of 1.60%to 3.64%(n=9).None of the above nine antifungal drug was detected in the 16 TCM cream preparations.Conclusion The established method is easy,reliable and accurate,which can be used for the rapid and effective detection of illegal addition of antifungal drugs in TCM external preparations.关键词
非法添加/超高效液相色谱串联质谱法/抗真菌药物/中药外用制剂Key words
illegal addition/UPLC-MS/MS/antifungal drug/external preparations of traditional Chinese medicine分类
医药卫生
