Methoxy-polyethylene glycol amine (mPEG-NH₂), an important pharmaceutical excipient, has been extensively utilized in the field of biomedicine. To advance the development of mPEG-NH₂-related drug delivery systems, it is crucial to understand the safety profile and cellular pharmacokinetic behavior of mPEG-NH₂ polymers. In this study, a straightforward analytical assay based on ultra-high performance liquid chromatography and tandem mass spectrometry (UHPLC-MS/MS) for quantifying mPEG 5 -NH₂ in biological matrices was established and validated. Multiple reaction monitoring (MRM) transitions were selected for quantification of mPEG 5 -NH₂ (mass-to-charge ratio, m/z 252.1 → 87.7) and octaethylene glycol (OH-PEG 8 -OH) (mass-to-charge ratio, m/z 371.2 → 89.2). The UHPLC-MS/MS assay demonstrated excellent linearity within the concentration range of 0.01–10 μg/mL, with an R² value of 0.9996. Both intra-day and inter-day accuracies and precisions of the analytical method were within ± 9.19 %. This analytical assay was successfully applied to study the in vitro cellular toxicity and uptake behavior of mPEG 5 -NH₂ in MCF-7 cells. The results indicate that high doses of mPEG 5 -NH₂ may have potential toxicity to MCF-7 cells.
As an important chemical reagent, methoxy polyethylene glycol amine (mPEG-NH 2 ) is widely used in biomedical field. Unraveling the pharmacokinetic behavior of mPEG-NH 2 polymers is essential for revealing the toxicity and efficiency of mPEG-NH 2 related drug delivery systems. In this study, a simple analytical assay based on mass spectrometry (MS) was first established and validated for quantification of mPEG 5 -NH 2 in biological matrix. The multiple reaction monitoring (MRM) transitions at m / z 252.2 (precursor ions) → 87.7 (fragment ions) and m / z 371.2 (precursor ions) → 89.2 (fragment ions) were chosen to determine mPEG 5 -NH 2 and OH-PEG 8 -OH, respectively. The UHPLC-MS/MS assay showed excellent linearity over the range of 0.01–10 μg/mL. Intra-day and inter-day accuracies and precisions of the assay were all within ± 6.44 %. The analytical assay was successfully applied to reveal the in vivo pharmacokinetic behavior of mPEG 5 -NH 2 in rats.
危险品化学品经营许可证（带存储）