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

Reverter-Branchat, Gemma; Groessl, Michael; Nakas, Christos T; Prost, Jean-Christophe; Antwi, Kwasi; Niederkofler, Eric E; Bally, Lia (2020). Rapid quantification of insulin degludec by immunopurification combined with liquid chromatography high-resolution mass spectrometry. Analytical and bioanalytical chemistry, 412(30), pp. 8351-8359. Springer 10.1007/s00216-020-02971-4

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Nephrology and Hypertension
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition

UniBE Contributor:

Reverter Branchat, Gemma; Grössl, Michael; Nakas, Christos T.; Prost, Jean-Christophe and Bally, Lia Claudia

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1618-2642

Publisher:

Springer

Language:

English

Submitter:

Karin Balmer

Date Deposited:

09 Nov 2020 08:39

Last Modified:

11 Mar 2021 19:10

Publisher DOI:

10.1007/s00216-020-02971-4

PubMed ID:

33006670

Uncontrolled Keywords:

Immunopurification Insulin degludec Mass spectrometry Quantification

BORIS DOI:

10.7892/boris.147769

URI:

https://boris.unibe.ch/id/eprint/147769

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