Determination of Nirmatrelvir in Mouse Plasma Based on the UPLC-MS/MS Method
10.3870/j.issn.1004-0781.2025.07.003
- VernacularTitle:超高效液相色谱-串联质谱法测定小鼠血浆奈玛特韦含量
- Author:
Songtao HUANG
1
;
Zhifa XIA
;
Zhenwei SHI
;
Xuan HU
;
Shusen YAO
;
Qiong WU
;
Fenghua XU
Author Information
1. 解放军总医院医疗保障中心,北京 100853;解放军医学院,北京 100853
- Publication Type:Journal Article
- Keywords:
Nirmatrelvir;
Ultra-high performance liquid chromatography-mass spectrometry method(UPLC-MS/MS);
Plasma drug concentration;
SARS-CoV-2
- From:
Herald of Medicine
2025;44(7):1035-1039
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop an ultra-high performance liquid chromatography-mass spectrometry method(UPLC-MS/MS)for the determination of nirmatrelvir concentration in mouse plasma.Methods The ACQUITY UPLC system was used in tandem with an API 4000 triple quadrupole mass spectrometer.The analytical column was Waters BEH C18(2.1 mm×5.0 mm,1.7 μm)column,and the mobile phases consisted of water(containing 0.1％formic acid)and methanol(containing 0.1％formic acid)under gradient elution at the flow rate of 0.4 mL·min-1.The column temperature was set at 40 ℃,and the injection volume was 5 μL.Electrospray ionization was used as ion source,and positive multiple reaction monitoring mode was adopted to quantitatively analyze the ionization pairs m/z 500.3→110.3(nirmatrelvir)and m/z 237.3→193.3(carbamazepine).Carbamazepine was employed as an internal standard.Results The linear range of nirmatrelvir was from 10 ng·mL-1 to 2 560 ng·mL-1.For the quality control nirmatrelvir samples,the accuracies of intra-and inter-batch were less than±15％,and the precisions of intra-and inter-batch were lower than 15％.Nirmatrelvir in plasma was stable at room temperature for 24 h and remained stable after three freeze-thaw cycles.The extracted nirmatrelvir solution could be stored at 4℃ for 3 d without any visible change.Conclusion The method was characterized by good specificity,high sensitivity,and appropriate linear range.The methodological validation was in accordance with the 2020 edition of the Chinese Pharmacopoeia and could be applied to the quantitative detection of nirmatrelvir in plasma.
