Determination of zanubrutinib in rat plasma by UHPLC-MS/MS method and its pharmacokinetics study
10.13699/j.cnki.1001-6821.2023.23.025
- VernacularTitle:用UHPLC-MS/MS法测定大鼠血浆中泽布替尼的浓度及药代动力学研究
- Author:
Fei-Fei CHEN
1
;
Yi-Ming HUANG
;
Yi-Feng LIN
;
Meng WANG
;
Rong-Rong ZHANG
;
Qi-Ying WANG
;
Guang-Hui ZHU
Author Information
1. 温州医科大学附属台州妇女儿童医院药剂科,浙江台州 318000;温州医科大学附属第二医院、育英儿童医院药学部,浙江温州 325000
- Keywords:
zanubrutinib;
ultra high performance liquid chromatography;
drug plasma concentration;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2023;39(23):3460-3463
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish an ultra-high performance liquid chromatography-tandem mass spectrometry for the determination of concentration of zanubrutinib in plasma.Method Multi-reaction ion(MRM)detection in positive mode is adopt in the method.The chromatographic column is ZORBAX Eclipse Plus C]8 column(1.8 μm,2.1 mm × 50.0 mm,I.D.Agilent Corporatio,MA,USA);Mobile phase:0.1％formic acid water and acetonitrile,gradient elution with a flow rate of 0.4 mL·min-1 and a volume of 2 μL was injected into the system.The plasma samples were prepared with acetonitrile for precipitation.After a single dose of 15 mg·kg-1 zanubrutinib for six adult male SD rats,blood was collected from the tail vein.The concentration of zanubrutinib in the rat plasma samples was measured,and the pharmacokinetic parameters were calculated by DAS 3.0.Result The linear range of zanubrutinib was 1-500 ng·mL-1 with good linearity.The intra-day and intra-day precision were less than 15％,and the relative recovery was 95.74％-99.19％.The absolution recovery,matrix effect and stability met the requirements;Pharmacokinetic parameters Cmax was(30.15±81.55)ng·mL-1,tmax was(0.32±0.16)h,t1/2 was(5.05±0.62)h,AUC0-t was(271.55±149.01)ng·h·mL-1.Conclusion The method for the determination of zanubrutinib in plasma established in this study has the characteristics of high sensitivity,rapid detection and good repeatability,and is suitable for the determination of zanubrutinib in plasma and the study of pharmacokinetics of zanubrutinib.
