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dc.contributor.authorGross, Peter C
dc.contributor.authorBurkart, Sonja C
dc.contributor.authorMüller, Rolf
dc.date.accessioned2013-12-11T13:45:10Z
dc.date.available2013-12-11T13:45:10Z
dc.date.issued2014-01
dc.identifier.citationAnalytics of the therapeutic peptide aviptadil by sheathless CE-MS and comparison with nanoRP-HPLC-MS. 2014, 88:477-82 J Pharm Biomed Analen
dc.identifier.issn1873-264X
dc.identifier.pmid24176753
dc.identifier.doi10.1016/j.jpba.2013.09.024
dc.identifier.urihttp://hdl.handle.net/10033/306712
dc.description.abstractPurification and quality control of therapeutic peptides is often performed by one single method, RP-HPLC. As usage of an orthogonal technique is highly advisable for quality assurance, capillary electrophoresis (CE) employing a coated capillary coupled via a sheathless interface to a mass spectrometer was applied in parallel. The basic therapeutic peptide aviptadil served as a model substance to study the impurity profiles revealing 15 detectable impurities using CE-MS, two were detected by an appropriate nanoRP-HPLC-MS method. None of the impurities detected by CE were observed in LC and vice versa. The LOD in CE-MS was determined in the base peak electropherogram at ∼1fmol, a value 2500 times smaller than the LOD found in nanoRP-HPLC-MS (3pmol). In nanoRP-HPLC-MS only 0.2% of the extrapolated CE-MS signal for a 25ng aviptadil load was observed. We conclude that both, the LOD as well as the impurity profile of aviptadil, as analyzed by nanoRP-HPLC are influenced by both, the ligand-derivatized silica matrix and the flow-rate. Peptides may disappear completely and their variable emergence may lead to the determination of incorrect ratios as present in the sample.
dc.language.isoenen
dc.rightsArchived with thanks to Journal of pharmaceutical and biomedical analysisen
dc.titleAnalytics of the therapeutic peptide aviptadil by sheathless CE-MS and comparison with nanoRP-HPLC-MS.en
dc.typeArticleen
dc.contributor.departmentBiotech Processes and Analytics Department, PharmBioTec GmbH, D-66123 Saarbrücken, Germany. Electronic address: p.gross@pharmbiotec.de.en
dc.identifier.journalJournal of pharmaceutical and biomedical analysisen
refterms.dateFOA2018-06-12T23:52:02Z
html.description.abstractPurification and quality control of therapeutic peptides is often performed by one single method, RP-HPLC. As usage of an orthogonal technique is highly advisable for quality assurance, capillary electrophoresis (CE) employing a coated capillary coupled via a sheathless interface to a mass spectrometer was applied in parallel. The basic therapeutic peptide aviptadil served as a model substance to study the impurity profiles revealing 15 detectable impurities using CE-MS, two were detected by an appropriate nanoRP-HPLC-MS method. None of the impurities detected by CE were observed in LC and vice versa. The LOD in CE-MS was determined in the base peak electropherogram at ∼1fmol, a value 2500 times smaller than the LOD found in nanoRP-HPLC-MS (3pmol). In nanoRP-HPLC-MS only 0.2% of the extrapolated CE-MS signal for a 25ng aviptadil load was observed. We conclude that both, the LOD as well as the impurity profile of aviptadil, as analyzed by nanoRP-HPLC are influenced by both, the ligand-derivatized silica matrix and the flow-rate. Peptides may disappear completely and their variable emergence may lead to the determination of incorrect ratios as present in the sample.


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