-
Tytuł:
-
Kinetic performance comparison of fully and superficially porous particles with a particle size of 5 µm: intrinsic evaluation and application to the impurity analysis of griseofulvin.
-
Autorzy:
-
Kahsay G; KU Leuven, Department of Pharmaceutical Sciences, Pharmaceutical Analysis, Herestraat 49, O&N 2, PB 923, 3000 Leuven, Belgium.
Broeckhoven K; Vrije Universiteit Brussel, Department of Chemical Engineering, Pleinlaan 2, 1050 Brussels, Belgium.
Adams E; KU Leuven, Department of Pharmaceutical Sciences, Pharmaceutical Analysis, Herestraat 49, O&N 2, PB 923, 3000 Leuven, Belgium.
Desmet G; Vrije Universiteit Brussel, Department of Chemical Engineering, Pleinlaan 2, 1050 Brussels, Belgium.
Cabooter D; KU Leuven, Department of Pharmaceutical Sciences, Pharmaceutical Analysis, Herestraat 49, O&N 2, PB 923, 3000 Leuven, Belgium. Electronic address: .
-
Źródło:
-
Talanta [Talanta] 2014 May; Vol. 122, pp. 122-9. Date of Electronic Publication: 2014 Jan 31.
-
Typ publikacji:
-
Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
-
Język:
-
English
-
Imprint Name(s):
-
Publication: Amsterdam : Elsevier
Original Publication: Oxford : Pergamon Press
-
MeSH Terms:
-
Drug Contamination*
Particle Size*
Griseofulvin/*analysis
Griseofulvin/*pharmacokinetics
Chromatography, High Pressure Liquid/methods ; Kinetics ; Porosity
-
Contributed Indexing:
-
Keywords: 5µm particles; Griseofulvin; Kinetic plots; Loadability; Superficially porous particles
-
Substance Nomenclature:
-
32HRV3E3D5 (Griseofulvin)
-
Entry Date(s):
-
Date Created: 20140412 Date Completed: 20150420 Latest Revision: 20140411
-
Update Code:
-
20240104
-
DOI:
-
10.1016/j.talanta.2014.01.050
-
PMID:
-
24720972
-
After the great commercial success of sub-3 µm superficially porous particles, vendors are now also starting to commercialize 5 µm superficially porous particles, as an alternative to their fully porous counterparts which are routinely used in pharmaceutical analysis. In this study, the performance of 5 µm superficially porous particles was compared to that of fully porous 5 µm particles in terms of efficiency, separation performance and loadability on a conventional HPLC instrument. Van Deemter and kinetic plots were first used to evaluate the efficiency and performance of both particle types using alkylphenones as a test mixture. The van Deemter and kinetic plots showed that the superficially porous particles provide a superior kinetic performance compared to the fully porous particles over the entire relevant range of separation conditions, when both support types were evaluated at the same operating pressure. The same observations were made both for isocratic and gradient analysis. The superior performance was further demonstrated for the separation of a pharmaceutical compound (griseofulvin) and its impurities, where a gain in analysis time of around 2 could be obtained using the superficially porous particles. Finally, both particle types were evaluated in terms of loadability by plotting the resolution of the active pharmaceutical ingredient and its closest impurity as a function of the signal-to-noise ratio obtained for the smallest impurity. It was demonstrated that the superficially porous particles show better separation performance for griseofulvin and its impurities without significantly compromising sensitivity due to loadability issues in comparison with their fully porous counterparts. Moreover these columns can be used on conventional equipment without modifications to obtain a significant improvement in analysis time.
(Copyright © 2014 Elsevier B.V. All rights reserved.)
