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Development and validation of a UPLC-MS/MS method for determination of SYHA1807 in a first-in-human study
Mengyang Yu1, Aijing Liu1, Shupeng Liu1
1Clinical 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.
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.
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