Rapid quantification of insulin degludec by immunopurification combined with liquid chromatography high-resolution mass spectrometry

Insulin degludec is an ultra-long-acting insulin analogue that is increasingly being used in diabetes due to its favourable efficacy and safety profile. Thus, there is an increasing demand for a reliable and specific analytical method to quantify insulin degludec for research, pharmaceutical industry and clinical applications. We developed and validated an automated, high-throughput method for quantification of insulin degludec in human blood samples across the expected clinical range combining immunopurification with high-resolution mass spectrometry. Validation was performed according to the requirements of the US Food and Drug Administration. The method satisfyingly met the following parameters: lower limit of quantification (120 pM), linearity, accuracy (error < 5%), precision (CV < 7.7%), selectivity, carry-over, recovery (89.7-97.2%), stability and performance in the presence of other insulin analogues. The method was successfully applied to clinical samples of patients treated with insulin degludec showing a good correlation with the administered dose (r2 = 0.78). High usability of the method is supported by the small specimen volume, automated sample processing and short analysis time. In conclusion, this reliable, easy-to-use and specific mass spectrometric insulin degludec assay offers great promise to address the current unmet need for standardized insulin analytics in academic and industrial research. Graphical Abstract.

Medienart:

E-Artikel

Erscheinungsjahr:

2020

Erschienen:

2020

Enthalten in:

Zur Gesamtaufnahme - volume:412

Enthalten in:

Analytical and bioanalytical chemistry - 412(2020), 30 vom: 02. Dez., Seite 8351-8359

Sprache:

Englisch

Beteiligte Personen:

Reverter-Branchat, Gemma [VerfasserIn]
Groessl, Michael [VerfasserIn]
Nakas, Christos T [VerfasserIn]
Prost, Jean-Christophe [VerfasserIn]
Antwi, Kwasi [VerfasserIn]
Niederkofler, Eric E [VerfasserIn]
Bally, Lia [VerfasserIn]

Links:

Volltext

Themen:

54Q18076QB
Immunopurification
Insulin, Long-Acting
Insulin degludec
Journal Article
Mass spectrometry
Quantification

Anmerkungen:

Date Completed 02.06.2021

Date Revised 02.06.2021

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1007/s00216-020-02971-4

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM315770430