An ultra-performance LC–MS/MS method for determination of JRF103 in human plasma: application in first in-patient study

Author:

Jin Ying1ORCID,Di Xiangjie1ORCID,Fu Lisha1ORCID,Zhang Mengyu1ORCID,Qiu Neng2,Liu Runhan1ORCID,Li Fangqun2,Qi Xiaohui1ORCID,Wang Xiaoxu2ORCID,Wang Yongsheng1,Wang Zhenlei1ORCID

Affiliation:

1. Clinical Trial Center/National Medical Products Administration Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital of Sichuan University, Chengdu, 610041, China

2. Shenzhen Jinrui Foundation Biotech Co., Ltd., Shenzhen, 518118, China

Abstract

Background: JRF103, a novel pan-HER inhibitor, has shown potent activity against HER1, HER2, HER4 and EGFR in vitro. To support its first in-patient trial, a sensitive and rapid method was developed and validated using ultra-performance LC–MS/MS. Materials & methods: JRF103 was extracted from plasma using protein precipitation. Extracts were subjected to ultra-performance LC–MS/MS with electrospray ionization. Results: Separation of analyte was achieved using a 1.7-μm C18 column (2.1 × 50-mm internal diameter) with a gradient elution. The developed method was fully validated following the international guides. Conclusion: The developed method was sensitive, specific and suitable for measuring JRF103 concentration in patients with advanced solid tumors in the first in-patient study of JRF103.

Funder

Youth Program of National Natural Science Foundation of China

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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