Rapid Determination of 23 Illegal Chemical Components in Adhesive Medical Devices by High-Performance Liquid Chromatography-Tandem Mass Spectrometry
Objective:To establish a rapid method for the determination of 23 kinds of chemical components illegally added in applied medical devices.Methods:Using high-performance liquid chromatography-tandem mass spectrometry,a detection method was established to simultaneously determine the illegal additives of 23 sympathomimetic and antihistamine drugs commonly used in clinical practice in adhesive medical devices.High-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)was used with Hypersil Gold 100mm×2.1mm,1.9μm column.The mobile phase was eluted with 0.01mol/L ammonium acetate(containing 0.1%formic acid)aqueous solution and acetonitrile;Volume flow rate 0.2mL/min;Column temperature 40˚C;Electrospray ion source positive and negative ion scanning mode;Multiple response detection mode detection was used to determine 23 illegal additives in applied medical devices.Results:A rapid separation and detection method for 23 kinds of illegal chemical components in applied medical devices was establishedChlorpheniramine maleate was detected in 1 batch of samples,and naphthozoline hydrochloride was detected in 1 batch of samples.Conclusion:The method is simple,rapid,accurate and sensitive,and can be used as a detection method for illegal addition of chemical drugs in medical devices,which provides a strong technical support for the supervision of applied medical devices.
high-performance liquid chromatography-tandem mass spectrometryillegal additionchemical components