Establishment and application of a rapid method for the determination of both total and unbound anlotinib concentrations by high-performance liquid chromatography–tandem mass spectrometry

IF 2.8 3区医学 Q2 BIOCHEMICAL RESEARCH METHODS

Journal of Chromatography B Pub Date : 2025-03-05 DOI:10.1016/j.jchromb.2025.124555

Min Zhang , Haichi Song , Zhongzhen Yuan , Tiantian Tang , Qiaoqiao Li , Jin Zeng , Lixian Li , Wanyi Chen

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引用次数: 0

Abstract

The unbound concentration of anlotinib is closely associated with its therapeutic efficacy and adverse reactions. In this study, we established an accurate and rapid liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the detection of total and unbound concentrations of anlotinib, which was subsequently applied to clinical samples. The separation of unbound and protein-bound anlotinib was achieved through filtration-ultrafiltration (CF-UF). Anlotinib-d5 served as the internal standard, and protein precipitation was utilized for sample preparation. The final method was thoroughly validated over a concentration range of 0.5–200 ng/mL according to related regulatory guidelines. Additionally, we demonstrated the clinical value of this method by analyzing blood samples from 39 lung cancer patients to quantify both total and unbound anlotinib concentrations. This method provides a foundation for further research into the relationship between anlotinib concentrations, therapeutic efficacy, and adverse reactions, ultimately facilitating the optimization of treatment strategies for patients.

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来源期刊

Journal of Chromatography B 医学-分析化学

CiteScore

5.60

自引率

3.30%

发文量

306

审稿时长

44 days

期刊介绍： The Journal of Chromatography B publishes papers on developments in separation science relevant to biology and biomedical research including both fundamental advances and applications. Analytical techniques which may be considered include the various facets of chromatography, electrophoresis and related methods, affinity and immunoaffinity-based methodologies, hyphenated and other multi-dimensional techniques, and microanalytical approaches. The journal also considers articles reporting developments in sample preparation, detection techniques including mass spectrometry, and data handling and analysis. Developments related to preparative separations for the isolation and purification of components of biological systems may be published, including chromatographic and electrophoretic methods, affinity separations, field flow fractionation and other preparative approaches. Applications to the analysis of biological systems and samples will be considered when the analytical science contains a significant element of novelty, e.g. a new approach to the separation of a compound, novel combination of analytical techniques, or significantly improved analytical performance.