New Materials Applied for the Stationary Phases in View of the Optimized HPLC and UHPLC Column Classification System Used in the Pharmaceutical Analysis

Abstract:

Pharmacopoeial monographs define usually requirements for the use of the particular chromatographic packing materials in a very general way. Even if a selection of particular chromatographic column packed with the defined material is suggested, it appears often that column is currently not present in the laboratory, or is no longer commercially available. With respect to those facts, there are needs to replace the given column material for another one, however with the similar physicochemical characteristics. This can be achieved by using one of the classification systems of columns’ material (e.g., the procedure developed by the researchers at the Katholieke Universiteit Leuven – and therefore called tentatively by us as KUL procedure).In the first stage of the work, it has been proven that the results obtained by KUL procedure can be related to results obtained during chemometrics verification of the suitability of selected stationary phases’ material used in the individual columns for purity test of alfuzosin as pharmaceutical substance and their impurities and related compounds. The next step was to adapt KUL procedure to allow the classification of modern and new UHPLC and Core-Shell (CS) columns’ material characterized by the novel physicochemical properties. Together, properties of 61 columns packed with variable materials have been characterized. The last step comprised the data collection to examine the possibilities to use UHPLC and CS columns materials as equivalent ones to the classical HPLC columns’ materials in view of the method transfer for the previously mentioned assay for alfuzosin.

• Periodical: Advanced Materials Research (Volumes 1120-1121)
• Pages: 1404-1412
• DOI: https://doi.org/10.4028/www.scientific.net/AMR.1120-1121.1404
• Online since: July 2015
• Authors: Alina Plenis*, Tomasz Bączek, Jarosław Szulfer, Michał Markuszewski
• Keywords: Chemometrics, Chromatographic Columns, Column Classification System, Core-Shell (CS) Columns, Pharmaceutical Substances, Stationary Phases Materials, UHPLC

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