Open AccessBioanalysis of INCB000928 in human saliva: nonspecific binding and inhomogeneous concentration
Author(s) -
Zhiyin Xun,
Brad Yuska,
Phillip Wang,
Swamy Yeleswaram
Publication year - 2022
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-2022-0016
Subject(s) - saliva , bioanalysis , chromatography , protein precipitation , chemistry , matrix (chemical analysis) , high performance liquid chromatography , biochemistry
Aim: To develop a bioanalytical method for quantifying INCB000928 in human saliva. Materials & methods: Human centrifuged saliva and human whole saliva were compared for matrix selection. Protein precipitation extraction and HPLC–MS/MS was used for analysis. Results & conclusion: Nonspecific binding of INCB000928 was reduced in whole versus centrifuged saliva. Whole saliva was a preferred matrix for INCB000928 bioanalytical method validation. Incurred sample reanalysis (ISR) using a successfully validated method failed in a healthy volunteer study because of inhomogeneous INCB000928 concentration across sample tube depths. Individual mixing of sample tubes followed by immediate aliquoting corrected the ISR failure, with 97.2% of repeats passing versus 41.7% for the same ISR samples.