Simultaneous quantitation of the BACE1 inhibitor AZD3293 and its metabolite AZ13569724 in human matrices by LC–MS/MS | Zendy

Li Yan | Zendy; Paul Severin | Zendy; Mark R. Hoffmann | Zendy; Dennis Miller | Zendy; Scott A. Monk | Zendy; Alan R. Kugler | Zendy

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Simultaneous quantitation of the BACE1 inhibitor AZD3293 and its metabolite AZ13569724 in human matrices by LC–MS/MS

Author(s) -

Li Yan,

Paul Severin,

Mark R. Hoffmann,

Dennis Miller,

Scott A. Monk,

Alan R. Kugler

Publication year - 2017

Publication title -

bioanalysis

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.566

H-Index - 58

eISSN - 1757-6199

pISSN - 1757-6180

DOI - 10.4155/bio-2017-0003

Subject(s) - metabolite , chromatography , protein precipitation , bioanalysis , chemistry , human plasma , ultrafiltration (renal) , analyte , active metabolite , urine , dilution , biochemistry , physics , thermodynamics

Aim: AZD3293 is a novel BACE1 inhibitor in Phase III development for Alzheimer's disease. Sensitive and robust bioanalytical methods were required to quantitate AZD3293 and its metabolite AZ13569724 in human biological matrices. Methodology/results: Human plasma was prepared by protein precipitation. Linearity for both analytes was in the range of 0.5–500 ng/ml with up to 100-fold dilution. Plasma ultrafiltrate samples were prepared using Centrifree ® ultrafiltration device. Urine and CSF samples were analyzed directly after dilution. A 27% decrease in AZD3293 concentrations in the CSF collection apparati was found due to nonspecific binding. Incurred sample reanalysis was acceptable. Conclusion: Methods for simultaneous quantitation of AZD3293 and its metabolite AZ13569724 in human biological matrices have been validated and successfully applied to clinical studies.

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