Analysis of protamine peptides in insulin pharmaceutical formulations by capillary electrophoresis

Journal of Separation Science
Caroline LamalleM Fillet

Abstract

Protamines are a group of highly basic peptides that are sometimes added to insulin formulations to prolong the pharmacological action. In this study, different methods were investigated to identify protamine in insulin formulations. Capillary electrophoresis in aqueous and non-aqueous media was tested to separate these peptides with very close amino acid sequences. Different buffers (phosphate or formate, both acidified) and various additives (principally negatively charged and neutral surfactants) were investigated to optimize peptide separation. Finally, a micellar electrokinetic capillary chromatography method using a capillary of 120 cm effective length and an aqueous background electrolyte made up of 100 mM phosphate buffer (pH 2) and 50 mM Thesit® gave the best results, providing the separation of the four major protamine peptides within 25 min.

References

Jan 27, 1999·Journal of Pharmaceutical and Biomedical Analysis·A SnycerskiJ Tautt
Apr 25, 2000·Nucleic Acids Research·M JunghansA Zimmer
Aug 7, 2001·Shokuhin eiseigaku zasshi. Journal of the Food Hygienic Society of Japan·M HirokadoM Nishijima
Jan 1, 1960·Advances in Protein Chemistry·K FELIX
Sep 15, 2004·International Journal of Pharmaceutics·Dirk LochmannAndreas Zimmer
Mar 3, 2005·Journal of Pharmaceutical and Biomedical Analysis·A Hvass, B Skelbaek-Pedersen
Feb 10, 2012·Journal of Pharmaceutical and Biomedical Analysis·David Awotwe-OtooRakhi B Shah
Jan 21, 2015·Journal of Pharmaceutical and Biomedical Analysis·Caroline LamalleMarianne Fillet

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Citations

Aug 14, 2019·Mass Spectrometry Reviews·Fabio P Gomes, John R Yates
Jan 4, 2018·Analytical Chemistry·Robert L C VoetenGovert W Somsen

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