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 |
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Erscheinungsjahr: |
2020 |
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Erschienen: |
2020 |
Enthalten in: |
Zur Gesamtaufnahme - volume:412 |
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Enthalten in: |
Analytical and bioanalytical chemistry - 412(2020), 30 vom: 02. Dez., Seite 8351-8359 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Reverter-Branchat, Gemma [VerfasserIn] |
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Links: |
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Themen: |
54Q18076QB |
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Anmerkungen: |
Date Completed 02.06.2021 Date Revised 02.06.2021 published: Print-Electronic Citation Status MEDLINE |
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doi: |
10.1007/s00216-020-02971-4 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM315770430 |
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520 | |a 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 Journal Article | |
650 | 4 | |a Immunopurification | |
650 | 4 | |a Insulin degludec | |
650 | 4 | |a Mass spectrometry | |
650 | 4 | |a Quantification | |
650 | 7 | |a Insulin, Long-Acting |2 NLM | |
650 | 7 | |a insulin degludec |2 NLM | |
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700 | 1 | |a Antwi, Kwasi |e verfasserin |4 aut | |
700 | 1 | |a Niederkofler, Eric E |e verfasserin |4 aut | |
700 | 1 | |a Bally, Lia |e verfasserin |4 aut | |
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