title: Comparison of core-shell and totally porous ultra high performance liquid chromatographic stationary phases based on their selectivity towards alfuzosin compounds.
abstract: This paper focuses on the application of a column classification system based on the Katholieke Universiteit Leuven for the characterization of physicochemical properties of core-shell and ultra-high performance liquid chromatographic stationary phases, followed by the verification of the reliability of the obtained column classification in pharmaceutical practice. In the study, 7 stationary phases produced in core-shell technology and 18 ultra-high performance liquid chromatographic columns were chromatographically tested, and ranking lists were built on the FKUL-values calculated against two selected reference columns. In the column performance test, an analysis of alfuzosin in the presence of related substances was carried out using the brands of the stationary phases with the highest ranking positions. Next, a system suitability test as described by the European Pharmacopoeia monograph was performed. Moreover, a study was also performed to achieve a purposeful shortening of the analysis time of the compounds of interest using the selected stationary phases. Finally, it was checked whether methods using core-shell and ultra-high performance liquid chromatographic columns can be an interesting alternative to the high-performance liquid chromatographic method for the analysis of alfuzosin in pharmaceutical practice.
authors.affiliation: Polpharma SA Pharmaceutical Works, Pelplińska 19, 83-200 Starogard Gdański, Poland.
authors.forename: Jarosław
authors.initials: J
authors.lastname: Szulfer
authors.affiliation: Department of Pharmaceutical Chemistry, Medical University of Gdańsk, Hallera 107, 80-416 Gdańsk, Poland.
authors.forename: Alina
authors.initials: A
authors.lastname: Plenis
authors.affiliation: Department of Pharmaceutical Chemistry, Medical University of Gdańsk, Hallera 107, 80-416 Gdańsk, Poland. Electronic address: tbaczek@gumed.edu.pl.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Bączek
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000592:standards*; D016062:Porosity; D011799:Quinazolines / Q000737:chemistry*; D015203:Reproducibility of Results
chemical_list: D011799:Quinazolines; C047638:alfuzosin
keywords: Alfuzosin; Column classification; High-performance liquid chromatography (HPLC); Impurities; The Katholieke Universiteit Leuven method (KUL method); Ultra-high performance liquid chromatography (UHPLC)