Comprehensive two-dimensional liquid chromatography separations of pharmaceutical samples using dual Fused-Core columns in the 2nd dimension

Journal of Chromatography. a
A J Alexander, Lianjia Ma

Abstract

This paper focuses on the application of RPLC x RPLC to pharmaceutical analysis and addresses the specific problem of separating co-eluting impurities/degradation products that maybe "hidden" within the peak envelope of the active pharmaceutical ingredient (API) and thus may escape detection by conventional methods. A comprehensive two-dimensional liquid chromatograph (LC x LC) was constructed from commercially available HPLC equipment. This system utilizes two independently configurable 2nd dimension binary pumping systems to deliver independent flow rates, gradient profiles and mobile phase compositions to dual Fused-Core secondary columns. Very fast gradient separations (30s total cycle time) were achieved at ambient temperature without excessive backpressure and without compromising optimal 1st dimension sampling rates. The operation of the interface is demonstrated for the analysis of a 1mg/ml standard mixture containing 0.05% of a minor component. The practicality of using RPLC x RPLC for the analysis of actual co-eluting pharmaceutical degradation products, by exploiting pH-induced changes in selectivity, is also demonstrated using a three component mixture. This mixture (an API, an oxidation product of the API at 1.0%, ...Continue Reading

References

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Citations

Apr 13, 2011·Analytical Chemistry·R K Gilpin, C S Gilpin
Apr 4, 2012·Analytical Chemistry·Jing LiuXudong Fan
Aug 30, 2012·Analytical Chemistry·Elena UliyanchenkoPeter J Schoenmakers
Dec 6, 2012·Bioanalysis·Nm CassianoQb Cass
Sep 24, 2015·Bioanalysis·Oskar GonzálezRosa M Alonso
Oct 20, 2014·Analytical and Bioanalytical Chemistry·Pavel JanderaMagda Staňková
Jun 29, 2016·Analytical and Bioanalytical Chemistry·Heba Shaaban
Nov 26, 2016·Journal of Separation Science·Petr Česla, Jana Křenková
Sep 2, 2010·Journal of Separation Science·Jared S BakerLuis A Colón
Mar 5, 2015·Journal of Separation Science·Danielle N BassanesePaul G Stevenson

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