Development and validation of a high-throughput and green ultra-performance convergence chromatography-tandem mass spectrometry assay for quantification of methoxy-polyethylene glycol propionic acid polymers.

As a synthetic polymer, methoxy-polyethylene glycol propionic acid (M-PEG-PA) is widely used in the biomedicine field. Unraveling the pharmacokinetic behavior of M-PEG6-PA in vivo is crucial for evaluating the safety and efficiency of M-PEG-PA-related polymers or drug delivery systems. A high-throughput and green ultra-performance convergence chromatography-tandem mass spectrometry (UPC2-MS/MS) assay was firstly developed and validated for the determination of M-PEG6-PA polymers in a biological matrix. The MRM transition (mass to charge ratio, precursor ions→fragment ions) of m/z 367.2→118.9 was used to quantify M-PEG6-PA in this study. The throughput of the assay is high and the total running time for each sample was only 2 min. The linear range of the developed UPC2-MS/MS assay for quantification of M-PEG6-PA in a biological matrix is 0.05 to 30 μg/mL (R≥0.995). Intra-day and inter-day precisions for the determination of M-PEG6-PA by this analytical assay were <6.99%. The absolute recoveries and matrix effects of M-PEG6-PA ranged from 79.50 to 92.47% and 68.72 to 81.73%, respectively. The UPC2-MS/MS assay was successfully applied to quantify the concentrations of M-PEG6-PA polymers in rat plasma samples.