Identification and characterization of stress degradation products of ibrutinib by LC-UV/PDA and LC-Q/TOF-MS studies.
Eur J Mass Spectrom (Chichester)
; 29(4): 248-261, 2023 Aug.
Article
in En
| MEDLINE
| ID: mdl-37612237
ABSTRACT
The anticancer drug ibrutinib was subjected to stress degradation studies under the ICH-prescribed hydrolytic, photolytic, oxidative and thermal stress conditions, and its degradation behavior was studied. A significant degradation was noted for the drug under acidic/alkaline hydrolytic, acid/alkaline photolytic, and oxidative conditions. The UPLC-UV/PDA studies revealed the generation of six degradation products (I-VI), and these were adequately resolved from the drug under the developed chromatographic conditions over a Kinetex® C18 (100â
mm×4.6â
mm; 2.6â
µm) column employing isocratic elution method. Detection wavelength was selected as 289â
nm. The UPLC-UV/PDA method conditions were extrapolated to UPLC-MS/TOF studies. All the six degradation products were found to be ionized in the total ion chromatogram, and the products could be identified and characterized from their mass spectral data. The possible degradation route of ibrutinib leading to generation of various products was also postulated.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Piperidines
/
Tandem Mass Spectrometry
Type of study:
Diagnostic_studies
Language:
En
Journal:
Eur J Mass Spectrom (Chichester)
Year:
2023
Document type:
Article