[Development and Application of a Method for Determining 33 Aromatic Primary Amines in Medical-Grade Thermoplastic Polyurethane by Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry].

Objective: To develop an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous determination of 33 aromatic primary amines in medical-grade thermoplastic polyurethane (TPU). Methods: The target compounds were extracted using 80% methanol and PBS solution containing 10% ethanol as the solvents. The 80% methanol extract was filtered through and diluted to one-fifth of the original concentration. The PBS extract was processed through an HLB solid-phase extraction column (3 mL, 60 mg, methanol and water equilibrium), eluted with 5 mL methanol, filtered, and diluted to 5 mL with methanol. Then, analysis was performed using UPLC-MS/MS. Chromatographic separation was performed using an Agilent InfinityLab Poroshell 120 EC-C18 column (150 mm × 3.0 mm, 2.7 μm) with methanol (A) and deionized water containing 0.1% formic acid (B) as the mobile phases. Gradient elution was conducted with a column temperature of 40 ℃, a flow rate of 0.2 mL/min, and an injection volume of 1 μL. Mass spectrometry analysis was performed using an electro-spray ionization (ESI) source in multiple reaction monitoring (MRM) positive ion mode. The standard curves, quantification limits, precision, recovery rates, and matrix effects of the method under different extraction conditions were evaluated. Results: The 33 aromatic primary amines analyzed in the study showed good linearity ( Conclusion: The UPLC-MS/MS method demonstrates high sensitivity and accuracy, meeting the requirements for precise detection of 33 aromatic primary amines in medical-grade TPU and providing reliable technical support for risk assessment and quality control of aromatic primary amines in these materials and products.