Rapid, direct, and sensitive determination of aziridine and 2-chloroethylamine by hydrophilic interaction liquid chromatography-mass spectrometry.

A rapid HILIC-MS method was developed for measuring the genotoxic impurities aziridine and 2-chloroethylamine. Sample preparation was simple and direct without requiring derivatization. Paired with a 1.5 min isocratic UHPLC separation, sample analysis could be completed in less than 5 min. Linearity was established from 0.5 μg/L to 10 μg/L for both target analytes. For main components at 100 g/L, this equates to 5 parts per billion (ppb) detectability using a benchtop, single quadrupole detector. Three model matrices were evaluated (glycine, phenylalanine, and the pharmaceutical drug asunaprevir), and the method was able to provide suitable repeatability (<10% RSD) and accuracy (±10%) at 5 μg/L concentrations. •Direct sample preparation without derivatization as is needed for GC analyses•Less than 5 min required for sample preparation and HILIC-MS analysis•Part per billion sensitivity in multiple test matrices with good recovery.

Pubmed ID: 31667117