Simultaneous determination of insulin and its analogues in pharmaceutical formulations by micellar electrokinetic chromatography

Lamalle, Caroline; Servais, Anne-Catherine; RADERMECKER, Régis; Crommen, Jacques; Fillet, Marianne

doi:10.1016/j.jpba.2014.12.038

Article (Scientific journals)

Simultaneous determination of insulin and its analogues in pharmaceutical formulations by micellar electrokinetic chromatography

Lamalle, Caroline; Servais, Anne-Catherine; RADERMECKER, Régis et al.

2015 • In Journal of Pharmaceutical and Biomedical Analysis

Peer Reviewed verified by ORBi

Permalink
https://hdl.handle.net/2268/180834

DOI
10.1016/j.jpba.2014.12.038

PubMed
25599910

Files (1)Send to Details Statistics Bibliography Similar publications

Files

Full Text

JPBA_insulin.pdf

Publisher postprint (1.36 MB)

Download

All documents in ORBi are protected by a user license.

Send to

RIS BibTex APA Chicago Permalink X Linkedin

Details

Keywords :

counterfeit medicines; insulin; micellar electrokinetic chromatography; quality control; stability

Abstract :

[en] A simple and efficient MEKC method was developed to simultaneously determine human insulin, its five analogues, the main degradation products and the excipients usually present in injection formulations. A very fast method with a total analysis time of 3 min was then successfully validated for the analysis of human insulin and the quality control of different commercial formulations was carried out.

Research Center/Unit :

Centre Interfacultaire de Recherche du Médicament - CIRM

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Lamalle, Caroline ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments

Servais, Anne-Catherine ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments

RADERMECKER, Régis ; Centre Hospitalier Universitaire de Liège - CHU > Diabétologie,nutrition, maladies métaboliques

Crommen, Jacques ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie

Fillet, Marianne ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments

Language :

English

Title :

Simultaneous determination of insulin and its analogues in pharmaceutical formulations by micellar electrokinetic chromatography

Publication date :

2015

Journal title :

Journal of Pharmaceutical and Biomedical Analysis

ISSN :

0731-7085

eISSN :

1873-264X

Publisher :

Elsevier Science, Oxford, United Kingdom

Peer reviewed :

Peer Reviewed verified by ORBi

Funders :

F.R.S.-FNRS - Fonds de la Recherche Scientifique

Available on ORBi :

since 24 April 2015

Statistics

Number of views

120 (16 by ULiège)

Number of downloads

1163 (11 by ULiège)

More statistics

Scopus citations^®

Scopus citations^®
without self-citations

OpenCitations

OpenAlex citations

Bibliography

Madsbad S. Insulin and new insulin analogues with focus on type 2 diabetes. Pharmacotherapy of Diabetes: New Developments 2007, 53-65. Springer, US. C.E. Mogensen (Ed.).
Tong W., Yeung E.S. Determination of insulin in single pancreatic cells by capillary electrophoresis and laser-induced native fluorescence. J. Chromatogr. B: Biomed. Appl. 1996, 685:35-40.
German I., Kennedy R.T. Rapid simultaneous determination of glucagon and insulin by capillary electrophoresis immunoassays. J. Chromatogr. B: Biomed. Sci. Appl. 2000, 742:353-362.
Solinova V., Kasicka V., Koval D., Barth T., Ciencialova A., Zakova L. Analysis of synthetic derivatives of peptide hormones by capillary zone electrophoresis and micellar electrokinetic chromatography with ultraviolet-absorption and laser-induced fluorescence detection. J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci. 2004, 808:75-82.
Le Potier I., Franck G., Smadja C., Varlet S., Taverna M. In-capillary derivatization approach applied to the analysis of insulin by capillary electrophoresis with laser-induced fluorescence detection. J. Chromatogr. A 2004, 1046:271-276.
Descroix S., Le Potier I., Niquet C., Minc N., Viovy J.L., Taverna M. In-capillary non-covalent labeling of insulin and one gastrointestinal peptide for their analyses by capillary electrophoresis with laser-induced fluorescence detection. J. Chromatogr. A 2005, 1087:203-209.
Thevis M., Thomas A., Delahaut P., Bosseloir A., Schanzer W. Qualitative determination of synthetic analogues of insulin in human plasma by immunoaffinity purification and liquid chromatography-tandem mass spectrometry for doping control purposes. Anal. Chem. 2005, 77:3579-3585.
Guillo C., Roper M.G. Two-color electrophoretic immunoassay for simultaneous measurement of insulin and glucagon content in islets of Langerhans. Electrophoresis 2008, 29:410-416.
Dishinger J.F., Reid K.R., Kennedy R.T. Quantitative monitoring of insulin secretion from single islets of Langerhans in parallel on a microfluidic chip. Anal. Chem. 2009, 81:3119-3127.
Guillo C., Truong T.M., Roper M.G. Simultaneous capillary electrophoresis competitive immunoassay for insulin, glucagon, and islet amyloid polypeptide secretion from mouse islets of Langerhans. J. Chromatogr. A 2011, 1218:4059-4064.
Hess C., Thomas A., Thevis M., Stratmann B., Quester W., Tschoepe D., Madea B., Musshoff F. Simultaneous determination and validated quantification of human insulin and its synthetic analogues in human blood serum by immunoaffinity purification and liquid chromatography-mass spectrometry. Anal. Bioanal. Chem. 2012, 404:1813-1822.
Kunkel A., Günter S., Dette C., Wätzig H. Quantitation of insulin by capillary electrophoresis and high-performance liquid chromatography. Method comparison and validation. J. Chromatogr. A 1997, 781:445-455.
Moslemi P., Najafabadi A.R., Tajerzadeh H. A rapid and sensitive method for simultaneous determination of insulin and A21-desamido insulin by high-performance liquid chromatography. J. Pharm. Biomed. Anal. 2003, 33:45-51.
Deng B., Liu Z., Luo G., Ma H., Duan M. Rapid quantitative determination and assessment of insulin in oil formulation by micellar electrokinetic capillary chromatography. J. Pharm. Biomed. Anal. 2002, 27:73-80.
Staub A., Rudaz S., Veuthey J.L., Schappler J. Multiple injection technique for the determination and quantitation of insulin formulations by capillary electrophoresis and time-of-flight mass spectrometry. J. Chromatogr. A 2010, 1217:8041-8047.
Ortner K., Buchberger W., Himmelsbach M. Capillary electrokinetic chromatography of insulin and related synthetic analogues. J. Chromatogr. A 2009, 1216:2953-2957.
Haunschmidt M., Ortner K., Hainz K., Bradt E., Sternbauer L., Buchberger W., Klampfl C.W. Investigations on the migration behavior of insulin and related synthetic analogues in CZE, MEKC and MEEKC employing different surfactants. Electrophoresis 2010, 31:1560-1564.
Yeh H.H., Wu H.L., Lu C.Y., Chen S.H. Simultaneous determination of regular insulin and insulin aspart by capillary zone electrophoresis and application in drug formulations. J. Pharm. Biomed. Anal. 2010, 53:145-150.
Visser N.F., van Harmelen M., Lingeman H., Irth H. On-line SPE-CE for the determination of insulin derivatives in biological fluids. J. Pharm. Biomed. Anal. 2003, 33:451-462.
Staub A., Guillarme D., Schappler J., Veuthey J.L., Rudaz S. Intact protein analysis in the biopharmaceutical field. J. Pharm. Biomed. Anal. 2011, 55:810-822.
Liu H.J., Strong R.E., Krull I.S., Cohen S.A. Homogeneous preparation of fluorescent-derivatized insulin and its application to competitive chromatographic immunoassays. Anal. Biochem. 2001, 298:103-111.
Nishi H., Terabe S. Micellar electrokinetic chromatography perspectives in drug analysis. J. Chromatogr. A 1996, 735:3-27.
Stanley B., Mehr K.A., Kellock T., Van Hamme J.D., Donkor K.K. Separation and determination of closely related lantibiotics by micellar electrokinetic chromatography. J. Sep. Sci. 2009, 32:2993-3000.
Wu Y., Xie J., Wang F., Chen Z. Separation of small molecular peptides with same amino acid composition but different sequences by capillary electrophoresis. J. Sep. Sci. 2009, 32:437-440.
Yashima T., Tsuchiya A., Morita O., Terabe S. Separation of closely related large peptides by micellar electrokinetic chromatography with organic modifiers. Anal. Chem. 1992, 64:2981-2984.
Arcelloni C., Falqui L., Martinenghi S., Pontiroli A.E., Paroni R. Capillary electrophoresis for simultaneous quantification of human proinsulin, insulin and intermediate forms. Electrophoresis 1998, 19:1475-1477.
Lamalle C., Servais A.C., Fradi I., Crommen J., Fillet M. Micellar electrokinetic chromatography systems for the separation of mixtures of charged and uncharged compounds. J. Sep. Sci. 2012, 35:1933-1939.
Brange J., Langkjaer L. Chemical stability of insulin. 3. Influence of excipients, formulation, and pH. Acta Pharm. Nord. 1992, 4:149-158.