Capillary Electrophoresis-Ultraviolet-Mass Spectrometry (CE-UV-MS) for the Simultaneous Determination and Quantification of Insulin Formulations
This chapter describes a CE-UV-MS method for the identification and quantification of insulin in pharmaceutical formulations in a single run. The CE conditions are optimized to avoid the adsorption of the protein onto the capillary wall. Particular attention is paid regarding the choice of the internal standard. A strategy based on multiple injections is applied to correct both ionization and injection variabilities. The methodology is validated according to international guidelines and the obtained accuracy profile demonstrates the ability of the CE-UV-MS method to quantify insulin in pharmaceutical formulations within a ±5 % acceptance range. This strategy can be implemented in the field of quality control, as well as in the detection of counterfeits.
Key wordsCapillary electrophoresis Identification Insulin Intact protein Multiple injections Quality control quantification Mass spectrometry
International Conference of Harmonization
Limit of detection
Relative standard deviation
Société Française des Sciences et Techniques Pharmaceutiques
Total ion electropherogram
Extracted ion electropherogram
The authors wish to thank Dr. Aline Staub Spörri from the Food Authority Control of Geneva for technical support and fruitful discussions.
- 3.Julie Schappler, Jean-Luc Veuthey, and Serge Rudaz (2008) Coupling CE and Microchip-Based Devices with Mass Spectrometry. In: Satinder Ahuja and M. Ilias Jimidar (eds), Separation Science and Technology, Vol 9, Capillary Electrophoresis Methods for Pharmaceutical Analysis, Academic Press: The Netherlands, pp 477–521. ISBN: 978-0-12-372573-8Google Scholar