A high-performance liquid chromatography-tandem mass spectrometry method for the determination of lifrafenib, a novel RAF kinase and EGFR inhibitor, in human plasma and urine and its application in clinical pharmacokinetic study.


Journal

Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Titre abrégé: J Pharm Biomed Anal
Pays: England
ID NLM: 8309336

Informations de publication

Date de publication:
20 Mar 2019
Historique:
received: 04 11 2018
accepted: 23 12 2018
pubmed: 2 1 2019
medline: 2 7 2019
entrez: 2 1 2019
Statut: ppublish

Résumé

Lifirafenib (BGB-283), a dual inhibitor trageting BRAF kinase and EGFR, showed favorable efficacy and safety in treating patients with different cancer types harboring mutations in BRAF, KRAS and NRAS. In order to support the clinical pharmacokinetic study, a sensitive high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed and validated to quantify lifirafenib concentration in human plasma and urine. Plasma samples were purified using protein precipitation. Urine samples were pre-treated by adding tween 80 with the purpose of preventing non-specific adsorption, then extracted by centrifugation. Chromatographic separation was achieved on Phenomenex Luna C

Identifiants

pubmed: 30599278
pii: S0731-7085(18)32481-6
doi: 10.1016/j.jpba.2018.12.038
pii:
doi:

Substances chimiques

BGB-283 0
Benzimidazoles 0
Naphthyridines 0

Types de publication

Clinical Trial, Phase I Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

20-29

Commentaires et corrections

Type : ErratumIn

Informations de copyright

Copyright © 2018 Elsevier B.V. All rights reserved.

Auteurs

Xueting Yao (X)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China.

Ling Song (L)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China.

Yang Liu (Y)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China.

Huanhuan Wang (H)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China.

Jie Liu (J)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China.

Ji Jiang (J)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China.

Dongyang Liu (D)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China. Electronic address: liudongyang@vip.sina.com.

Pei Hu (P)

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs, Beijing 100032, China. Electronic address: hubei01_pumch@163.com.

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Classifications MeSH