Development, validation and application of a liquid chromatography–tandem mass spectrometry method for the activity and inhibition of DPP-4-Reference-Cited by-同舟云学术

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

Published:2022-03 Issue:6 Volume:14 Page:369-378
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Bronsema Kees J¹,Lambert Wietske¹,Charmont Stephane²,Sangana Ramachandra³,Trigt Radboud van¹,Valentin Marie-Anne²

Affiliation:

1. ICON, Early Development Services Laboratory, Assen, TK, 9407, The Netherlands

2. Novartis Pharma AG, Biomarker Development, Basel, CH-4056, Switzerland

3. Novartis Healthcare Private Limited, Hyderabad, 500081, India

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2022-0004

Reference11 articles.

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4. Accurate and sensitive detection of dipeptidyl peptidase-IV activity by liquid chromatography with fluorescence detection

5. Center for Drug Evaluation and Research, US FDA. Bioanalytical Method Validation, Guidance for Industry (2018). https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf