Abstract:
Using 0.9% (mass fraction, the same below) sodium chloride solution as the infusion drug, simulating the intravenous drip method, 0.9% sodium chloride solution flowed through the tube of disposable infusion set at a rate of 40-60 drops·min
−1. An aliquot (5.0 mL) of the effluent (migration solution) was taken, placed into a headspace vial, and equilibrated at 80 ℃ for 30 min. The resulting gas flowed into the gas chromatograph-triple quadrupole mass spectrometer. The 14 solvents were separated using the heating program on the TG-624Sil MS chromatographic column, ionized by EI ion source, detected by SRM mode, and quantified by external standard method. It was shown that linear relationships between values of the mass concentrations and corresponding peak areas of 14 solvents were kept in definite ranges, with detection limits (3S/N) in the range of 0.1-0.2 μg·L
−1. The spiked recovery test was made at 3 concentration levels using 0.9% sodium chloride solution as the migration matrix, giving recoveries in the range of 80.0%-122%, and RSDs (
n=6) of the determined values ranged from 0.42% to 9.7%. The proposed method was used for the analysis of samples from different manufacturers. Seven solvents migrated to 0.9% sodium chloride solution, and the migration from samples of different manufacturers varied. The migration of cyclohexanone and 2-ethylhexanol from samples made of PVC was significantly higher than that from samples made of TPE, and the migration in old batches of samples from the same manufacturer was higher than that in new batches.