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.

SUBMITTER: Reverter-Branchat G 

PROVIDER: S-EPMC7680744 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature