Development, validation and application of a liquid chromatography-tandem mass spectrometry method for the activity and inhibition of DPP-4.
Bioanalysis
; 14(6): 369-378, 2022 Mar.
Article
em En
| MEDLINE
| ID: mdl-35249375
ABSTRACT
Background:
Inhibition of the enzyme dipeptidyl peptidase 4 (DPP-4) is a pharmaceutical treatment for type 2 diabetes. To demonstrate bioequivalence of enzyme inhibition of a new dosage form of the inhibitor vildagliptin, a method for enzyme activity was developed, validated and applied using liquid chromatography and tandem mass spectrometry (LC-MS/MS).Results:
The method was validated fit for purpose, including accuracy, precision as well as the stability of the activity and the inhibition of DPP-4 in human plasma.Conclusion:
A method for the determination of the activity and inhibition of DPP-4 was developed using LC-MS/MS readout; the characteristics and performance of the method met predefined acceptance criteria and were fit for the purpose of a bioequivalence clinical trial.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Dipeptidil Peptidase 4
/
Inibidores da Dipeptidil Peptidase IV
/
Compostos de Anilina
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article