Entecavir HPLC-MS/MS quantitation and optimized sample preparation using human plasma: Validation in a pharmacokinetic study.

Authors

Rui Zhao, Pengfei Li, Hongchuan Liu, Ping Du, Lihong Liu

Published in

International journal of clinical pharmacology and therapeutics. Oct 28, 2025. Epub Oct 28, 2025.

Abstract

To determine the entecavir levels in human plasma using a quantitative high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) technique.
The developed method employed isotope-labeled internal standard, a high-throughput solid phase extraction process for sample preparation, and HPLC-MS/MS analysis using multiple reaction monitoring transitions in positive mode.
With a 0.025 - 10 ng/mL linear range, interday and intraday accuracy ranged from -3.4 to 5.3%; between-day and within-day precision was ≤ 7.3%. Stability, matrix effect, and recovery were all well within the acceptable criteria. A pharmacokinetic study of entecavir dispersible tablets at an oral dosage of 0.5 mg was successfully carried out using the validated method.
The established HPLC-MS/MS method proved effective for quantitation of entecavir in human plasma.

PMID:
41147151
Bibliographic data and abstract were imported from PubMed on 28 Oct 2025.

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