This paper investigates the performance of a column classification system developed at the Katholieke Universiteit Leuven applied to pharmaceutical chromatographic analyses. The liquid chromatography assay of lamotrigine and related compounds was carried out according to the method prescribed in the European Pharmacopoeia monograph, using 28 brands of stationary phases. A ranking was built based on the FKUL value calculated against the selected reference column, then compared with the column test performance established for the stationary phases studied. Therefore, the system suitability test prescribed by the European Pharmacopoeia in order to distinguish between suitable or unsuitable columns for this analysis was evaluated. Moreover, it was examined whether the classes of the stationary phases, determined using test parameter results, contain either suitable or unsuitable supports for the lamotrigine separation. This assay was performed using chemometric a technique, namely factor analysis.FigureChemometric evaluation of the column classiffication system in pharmaceutical practice
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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.