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Analytical and Bioanalytical Chemistry

, Volume 407, Issue 25, pp 7637–7646 | Cite as

Fast analysis of glibenclamide and its impurities: quality by design framework in capillary electrophoresis method development

  • Sandra FurlanettoEmail author
  • Serena OrlandiniEmail author
  • Benedetta Pasquini
  • Claudia Caprini
  • Paola Mura
  • Sergio Pinzauti
Research Paper

Abstract

A fast capillary zone electrophoresis method for the simultaneous analysis of glibenclamide and its impurities (IA and IB) in pharmaceutical dosage forms was fully developed within a quality by design framework. Critical quality attributes were represented by IA peak efficiency, critical resolution between glibenclamide and IB, and analysis time. Experimental design was efficiently used for rapid and systematic method optimization. A 35//16 symmetric screening matrix was chosen for investigation of the five selected critical process parameters throughout the knowledge space, and the results obtained were the basis for the planning of the subsequent response surface study. A Box–Behnken design for three factors allowed the contour plots to be drawn and the design space to be identified by introduction of the concept of probability. The design space corresponded to the multidimensional region where all the critical quality attributes reached the desired values with a degree of probability π ≥ 90%. Under the selected working conditions, the full separation of the analytes was obtained in less than 2 min. A full factorial design simultaneously allowed the design space to be validated and method robustness to be tested. A control strategy was finally implemented by means of a system suitability test. The method was fully validated and was applied to real samples of glibenclamide tablets.

Graphical Abstract

Identification of sequence variants in IgG Fc mixtures

Keywords

Capillary electrophoresis Design of experiments Design space Glibenclamide Impurities Quality by design 

Notes

Acknowledgments

The authors thank Ente Cassa di Risparmio di Firenze for financial support and A. Menarini Industrie Farmaceutiche Riunite (Florence, Italy) for the gift of glibenclamide.

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

216_2015_8921_MOESM1_ESM.pdf (259 kb)
ESM 1 (PDF 258 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Sandra Furlanetto
    • 1
    Email author
  • Serena Orlandini
    • 1
    Email author
  • Benedetta Pasquini
    • 1
  • Claudia Caprini
    • 1
  • Paola Mura
    • 1
  • Sergio Pinzauti
    • 1
  1. 1.Department of Chemistry “U. Schiff”University of FlorenceSesto FiorentinoItaly

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