Development and validation of a UPLC-HR-SIM method to quantify semaglutide for its pharmacokinetic study

Intelligent Pharmacy Pub Date : 2025-04-01 DOI:10.1016/j.ipha.2025.01.002

Xinyi Jiang , Tong Li , Meng Yu , Yiran Zhao , Xiangyi Wang , Yanhe Zhou , Xinmiao Guo , Jiuming He , Jianpeng Huang

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Abstract

Aim

To develop a highly sensitive and interference-resistant ultra performance liquid chromatography (UPLC) coupled with high-resolution selected ion monitoring (HR-SIM) mass spectrometry method for the quantification of semaglutide in biological samples, and to apply it for pharmacokinetic analysis.

Method

The UPLC-HR-SIM method was utilized to quantify semaglutide in beagle plasma, requiring minimal sample pretreatment. The method demonstrated a lower limit of quantification (LLOQ) of 5.0 ng/mL for semaglutide in beagle plasma.

Results

Following intravenous (iv) administration at a dose of 0.030 mg/kg, the plasma concentration of semaglutide in beagles exhibited a multi-exponential decay pattern, with an average elimination half-life (t_1/2) of 44.90 ± 11.45 h.

Conclusions

The UPLC-HR-SIM method has proven to be a highly sensitive and robust approach for the quantification of peptide-based drugs. This method will enhance the understanding of the pharmacokinetics and pharmacodynamics of semaglutide and facilitate further research into the pharmacokinetics of other peptide therapeutics.

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开发和验证UPLC-HR-SIM方法定量西马鲁肽的药代动力学研究

目的建立一种高灵敏度、高抗干扰的超高效液相色谱（UPLC）联用高分辨率选择离子监测（HR-SIM）质谱法定量生物样品中semaglutide的方法，并将其应用于药代动力学分析。方法采用UPLC-HR-SIM法定量比格犬血浆中的半马鲁肽。该方法测定比格犬血浆中半马鲁肽的定量下限为5.0 ng/mL。结果静脉给药0.030 mg/kg后，小猎犬血药浓度呈多指数衰减，平均消除半衰期（t1/2）为44.90±11.45 h。结论UPLC-HR-SIM方法是一种灵敏、可靠的肽类药物定量方法。该方法将加深对西马鲁肽药代动力学和药效学的认识，并为进一步研究其他肽类药物的药代动力学提供便利。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Intelligent Pharmacy

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