Objective To establish a rapid and novel analytical method using ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)for the qualitative and quantitative determination of illegally added methyl salicylate in topical medical devices.The samples were extracted with methanol,filtered,and then analyzed using UPLC-MS/MS.Methods The separation was performed on a WATERS ACQUITY UPLC BEH C18 column(2.1×100 mm,1.7 μm)with a gradient elution of 0.05%ammonia solution-methanol as the mobile phase.Electrospray ionization(ESI)in negative ion mode and multiple reaction monitoring(MRM)were used for data acquisition.Results The linear relationship of methyl salicylate was good within the range of 1~100 μg/ml,with a correlation coefficient of 0.9997.The average recovery rate of three spiked levels was 90.3%~100.7%,with a relative standard deviation(RSD)of 0.5%~0.9%.The limit of detection(LOD)of the method was 0.1 μg/ml,and the limit of quantitation(LOQ)was 0.3 μg/ml.Methyl salicylate was detected in 29 out of 114 samples,with a content ranging from 1 to 47 mg per patch.Conclusion This method is characterized by its high specificity,accuracy,speed,and sensitivity,and is suitable for the qualitative and quantitative determination of illegally added methyl salicylate in medical dressings.