Charmont, Stephane, Sangana, Ramachandra and Valentin, Marie-Anne (2022) Development, validation and application of a liquid chromatography-tandem mass spectrometry method for the activity and inhibition of DPP-4. Bioanalysis, 14 (6). pp. 369-378. ISSN 1757-6199

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.

Item Type:	Article
Keywords:	Aniline Compounds Chromatography, Liquid Diabetes Mellitus, Type 2 Dipeptidyl Peptidase 4 Dipeptidyl-Peptidase IV Inhibitors Humans Molecular Structure Tandem Mass Spectrometry
Date Deposited:	10 May 2022 00:45
Last Modified:	10 May 2022 00:45
URI:	https://oak.novartis.com/id/eprint/46514