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Multiple injection technique for the determination and quantitation of insulin formulations by capillary electrophoresis and time-of-flight mass spectrometry |
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| Authors: | Aline Staub Serge Rudaz Jean-Luc Veuthey Julie Schappler |
| Affiliation: | 1. School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Bd d’Yvoy 20, 1211 Geneva 4, Switzerland;2. Swiss Centre for Applied Human Toxicology (SCAHT), University of Geneva, CMU, Rue Michel Servet 1, 1211 Geneva 4, Switzerland |
| Abstract: | This paper describes an efficient CE-UV-ESI-TOF/MS method for the determination and quantitation of intact insulin (INS) in a pharmaceutical formulation. The CE conditions were optimized to avoid the adsorption of proteins onto the capillary wall. Particular attention was paid regarding the choice of the internal standard (IS). A strategy based on multiple injections was selected and the methodology was validated according to international guidelines. The optimized method was applied with success to the analysis of INS formulations obtained from regular and parallel markets. |
| Keywords: | Capillary electrophoresis Intact protein Multiple injection Quantitation Time-of-flight mass spectrometry |
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