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一种用于定量甲氧基聚乙二醇丙酸聚合物的高通量绿色超高效汇聚色谱-串联质谱分析方法的开发与验证

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.

作者信息

Feng Chunpeng, Tian Jiye, Fang Qisheng, Cheng Yajie, Deng Yue, Zhang JiaRui, Feng Shuang, Wang Qingbin, Wang Hecheng, Zhao Xuan, Yin Lei

机构信息

Central Hospital of Dalian University of Technology, Dalian University of Technology, Dalian, Liaoning, 116023, PR China.

School of Chemical Engineering, Ocean and Life Sciences, Dalian University of Technology, Panjin, Liaoning, 124221, China.

出版信息

Anal Bioanal Chem. 2025 Mar 26. doi: 10.1007/s00216-025-05849-5.

DOI:10.1007/s00216-025-05849-5
PMID:40140066
Abstract

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-PEG-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 (UPC-MS/MS) assay was firstly developed and validated for the determination of M-PEG-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-PEG-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 UPC-MS/MS assay for quantification of M-PEG-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-PEG-PA by this analytical assay were <6.99%. The absolute recoveries and matrix effects of M-PEG-PA ranged from 79.50 to 92.47% and 68.72 to 81.73%, respectively. The UPC-MS/MS assay was successfully applied to quantify the concentrations of M-PEG-PA polymers in rat plasma samples.

摘要

作为一种合成聚合物,甲氧基聚乙二醇丙酸酯(M-PEG-PA)在生物医药领域有着广泛应用。阐明M-PEG-PA在体内的药代动力学行为对于评估与M-PEG-PA相关的聚合物或药物递送系统的安全性和有效性至关重要。首次开发并验证了一种高通量绿色超高效汇聚色谱-串联质谱(UPC-MS/MS)分析法,用于测定生物基质中的M-PEG-PA聚合物。本研究中使用质荷比为m/z 367.2→118.9的多反应监测(MRM)转换(质量电荷比,母离子→子离子)来定量M-PEG-PA。该分析方法通量高,每个样品的总运行时间仅为2分钟。所开发的用于生物基质中M-PEG-PA定量的UPC-MS/MS分析方法的线性范围为0.05至30μg/mL(R≥0.995)。该分析方法测定M-PEG-PA的日内和日间精密度均<6.99%。M-PEG-PA的绝对回收率和基质效应分别为79.50%至92.47%和68.72%至81.73%。该UPC-MS/MS分析方法已成功应用于定量大鼠血浆样品中M-PEG-PA聚合物的浓度。

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