Quantification of SHR0302 in human plasma by UPLC-MS/MS and application to a pharmacokinetic study.
Biomed Chromatogr
; 36(11): e5474, 2022 Nov.
Article
en En
| MEDLINE
| ID: mdl-35916260
ABSTRACT
SHR0302, as a novel Janus kinase (JAK) inhibitor 1, is used for treatment of rheumatoid arthritis (RA) in humans. A novel and sensitive ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) has been developed and validated for determining the concentration of SHR0302 in human plasma. A precipitation deproteinization method was used for plasma pretreatment with methanol. Detection was carried out on an Agilent 1,260 UPLC coupled with a Triple Quad 4000 mass spectrometer operated in positive multiple reaction monitoring mode, and the analytes were separated on a Synergi Polar-RP C18 (50 × 2.0 mm, 4 µm, Phenomenex) analytical column with gradient elution of 0.1% formic acid, and 2 mmol/l ammonium acetate in water and 0.1% formic acid and 2 mmol/l ammonium acetate in methanol, The selected ion transitions were m/z 415.2 â 258.2 and m/z 398.2 â 258.2 for SHR0302 and SHR143181 (internal standard), respectively. A full validation, including selectivity, linearity, carryover, precision, accuracy, recovery, matrix effect, dilution integrity and stability, was carried out in human plasma. It was successfully applied to a pharmacokinetic study in Chinese healthy subjects after oral administration of SHR0302 tablet.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Metanol
/
Espectrometría de Masas en Tándem
Límite:
Humans
Idioma:
En
Revista:
Biomed Chromatogr
Año:
2022
Tipo del documento:
Article
País de afiliación:
China