Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities

Journal of Pharmaceutical and Biomedical Analysis
Marko JovanovićBiljana Jančić Stojanović

Abstract

This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm × 4.6 mm, 5 μ...Continue Reading

References

Sep 15, 2006·Journal of Separation Science·Petrus Hemström, Knut Irgum
Mar 2, 2010·Journal of Chromatography. a·I MolnárK E Monks
Sep 7, 2011·Journal of Pharmaceutical and Biomedical Analysis·K E MonksI Molnár
Sep 4, 2012·Analytical and Bioanalytical Chemistry·Serena OrlandiniSandra Furlanetto
Oct 12, 2013·Journal of Separation Science·Silvia EcheverríaEva Pocurull

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Citations

Jan 18, 2020·Journal of Chromatographic Science·Daniel da Mota Castelo BrancoDavi Pereira de Santana

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