Development, validation and application of a liquid chromatography–tandem mass spectrometry method for the activity and inhibition of DPP-4

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 chromatogra...

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Bibliographic Details
Published in:Bioanalysis 2022-03, Vol.14 (6), p.369-378
Main Authors: Bronsema, Kees J, Lambert, Wietske, Charmont, Stephane, Sangana, Ramachandra, Trigt, Radboud van, Valentin, Marie-Anne
Format: Article
Language:English
Subjects:
accuracy
bioequivalence
DPP-4
enzyme inhibition
LC-MS/MS
validation
vildagliptin
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Summary: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). 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. 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.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2022-0004