Development and validation of a high performance liquid chromatography–MS/MS method for determination of SOMCL-15-290 in a first-in-human study

Author:

Wu Xiaofei12ORCID,Zhang Fan12,Liu Aijing12,Yu Mengyang12,Wang Hongyun12ORCID

Affiliation:

1. Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

2. 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, Beijing, 100730, China

Abstract

Background: SOMCL-15-290 is a novel inhibitor that targets FGF receptor, CSF1 receptor and VEGF receptor (kinase insert domain receptor). Aim: This study was aiming at developing a specific high performance liquid chromatography–MS/MS method for quantifying SOMCL-15-290 in human plasma and supporting the first-in-human study. Methods: Plasma samples were prepared using the protein precipitation method and separated on a C18 110A column with acetonitrile and 0.2% formic acid solution as mobile phases. Quantification of SOMCL-15-290 was operated on an Xevo-TQS triple quadrupole tandem mass spectrometer in electrospray ionization positive mode. Results & conclusion: The validated determination method of SOMCL-15-290 has proved feasible and was successfully utilized in the first-in-human study of SOMCL-15-290 in advanced solid tumor patients.

Funder

Ministry of Science and Technology of the People's Republic 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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