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

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

Abstract 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. Okt., 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 [kostenfrei]

BKL:	35.23$jAnalytische Chemie: Allgemeines 35.71$jBiochemische Methoden 42.03$jMethoden und Techniken der Biologie
Themen:	Immunopurification Insulin degludec Mass spectrometry Quantification

RVK:	RVK Klassifikation ELIB10

Anmerkungen:	© The Author(s) 2020

doi:	10.1007/s00216-020-02971-4

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	OLC2121413170

Internformat


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520			\|a Abstract 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
650		4	\|a Insulin degludec
650		4	\|a Immunopurification
650		4	\|a Mass spectrometry
650		4	\|a Quantification
700	1		\|a Groessl, Michael \|0 (orcid)0000-0002-6740-5980 \|4 aut
700	1		\|a Nakas, Christos T \|4 aut
700	1		\|a Prost, Jean-Christophe \|4 aut
700	1		\|a Antwi, Kwasi \|4 aut
700	1		\|a Niederkofler, Eric E. \|4 aut
700	1		\|a Bally, Lia \|4 aut
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856	4	0	\|u https://dx.doi.org/10.1007/s00216-020-02971-4 \|z kostenfrei \|3 Volltext
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Rapid quantification of insulin degludec by immunopurification combined with liquid chromatography high-resolution mass spectrometry

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