Capillary Electrophoresis-Ultraviolet-Mass Spectrometry (CE-UV-MS) for the Simultaneous Determination and Quantification of Insulin Formulations

Protocol
Part of the Methods in Molecular Biology book series (MIMB, volume 1466)

Abstract

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 words

Capillary electrophoresis Identification Insulin Intact protein Multiple injections Quality control quantification Mass spectrometry 

Abbreviations

ACN

Acetonitrile

BGE

Background electrolyte

CE

Capillary electrophoresis

ddH2O

Double-distilled water

EOF

Electroosmotic flow

ESI

Electrospray ionization

FS

Fused silica

I.D.

Internal diameter

ICH

International Conference of Harmonization

iPrOH

Isopropanol

LOD

Limit of detection

m/z

Mass-to-charge ratio

MeOH

Methanol

MS

Mass spectrometry

RSD

Relative standard deviation

S/N

Signal-to-noise ratio

SFSTP

Société Française des Sciences et Techniques Pharmaceutiques

TIE

Total ion electropherogram

TOF

Time-of-flight

UV

Ultraviolet

XIE

Extracted ion electropherogram

Notes

Acknowledgments

The authors wish to thank Dr. Aline Staub Spörri from the Food Authority Control of Geneva for technical support and fruitful discussions.

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  1. 1.School of pharmaceutical sciencesUniversity of Geneva, University of LausanneGeneva 4Switzerland

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