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Quantitative analysis of polypeptide pharmaceuticals by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
2008 (English)In: Journal of Pharmaceutical and Biomedical Analysis, ISSN 0731-7085, E-ISSN 1873-264X, Vol. 46, no 3, 411-417 p.Article in journal (Refereed) Published
Abstract [en]

An accurate method based on matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) has been developed for quantitative analysis of calcitonin and insulin in different commercially available pharmaceutical products. Tryptic peptides derived from these polypeptides were chemically modified at their C-terminal lysine-residues with 2-methoxy-4,5-dihydro-imidazole (light tagging) as standard and deuterated 2-methoxy-4,5-dihydro-imidazole (heavy tagging) as internal standard (IS). The heavy modified tryptic peptides (4D-Lys tag), differed by four atomic mass units from the corresponding light labelled counterparts (4H-Lys tag). The normalized peak areas (the ratio between the light and heavy tagged peptides) were used to construct a standard curve to determine the concentration of the analytes. The concentrations of calcitonin and insulin content of the analyzed pharmaceutical products were accurately determined, and less than 5% error was obtained between the present method and the manufacturer specified values. It was also found that the cysteine residues in CSNLSTCVLGK from tryptic calcitonin were converted to lanthionine by the loss of one sulfhydryl group during the labelling procedure.

Place, publisher, year, edition, pages
2008. Vol. 46, no 3, 411-417 p.
Keyword [en]
calcitonin, human insulin, MALDI-TOF-MS, quantification, injection solution and suspension
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-15865DOI: 10.1016/j.jpba.2007.10.028ISI: 000253100400001PubMedID: 18068324OAI: oai:DiVA.org:uu-15865DiVA: diva2:43636
Available from: 2008-03-11 Created: 2008-03-11 Last updated: 2017-12-08Bibliographically approved

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Amini, AhmadNilsson, Elin

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