Development and validation of a UPLC–MS/MS method for determination of SYHA1807 in a first-in-human study-Reference-Cited by-同舟云学术

Development and validation of a UPLC–MS/MS method for determination of SYHA1807 in a first-in-human study

Published:2023-12 Issue:24 Volume:15 Page:1489-1501
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Yu Mengyang¹,Liu Aijing¹,Liu Shupeng¹,Wu Xiaofei¹^ORCID,Zhang Xueyuan²,Li He²,Wang Hongyun¹^ORCID

Affiliation:

1. Clinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe & Rare Diseases, NMPA Key Laboratory for Clinical Research & Evaluation of Drug, Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, no. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China

2. CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd, Shijiazhuang, Hebei, China

Abstract

Background: SYHA1807 is a novel lysine specific demethylase 1 inhibitor being developed for the treatment of small-cell lung cancer. Aim: This study aimed to establish a ultra-performance liquid chromatography-mass spectrometry (UPLC–MS)/MS method for measuring SYHA1807 in human plasma, supporting its application in a first-in-human study. Methods: SYHA1807 was separated on an ACQUITY UPLC BEH® C18 Column (2.1 × 50 mm, 1.7 μm) after protein precipitation of plasma samples. Mass spectrometry analysis was performed with a Xevo TQS triple quadrupole mass spectrometer utilizing a positive electronic spray ionization source. The established method was fully validated according to bioanalytical guidelines. Results & conclusion: A rapid, specific and robust UPLC–MS/MS method was first established for quantifying SYHA1807 and successfully applied in a first-in-human study.

Funder

National High Level Hospital Clinical Research

National Key R&D Program of China

Publisher

Future Science Ltd

Subject

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

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2023-0143

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