Haidar Ahmad, Imad and Blasko, Andrei (2018) Two Dimensional Liquid Chromatography (2DLC) in pharmaceutical analysis. Applications beyond increasing peak capacity. Chromatographia, 81. pp. 401-418. ISSN 0009-5893

Abstract

One-dimensional liquid chromatography (1DLC) is not always capable of efficiently separating complex samples. This drawback is not solely due to the lack of column efficiency but is mainly due to insufficient selectivity and the need to separate the analytes of interest with orthogonal retention mechanisms. In this regard, two-dimensional liquid chromatography (2DLC) is currently attracting much interest for its markedly higher resolving power compared to one dimensional separation. In this work, three applications of 2DLC from the pharmaceutical industry are presented with the goal not only to increase peak capacity but also to support investigations and audits. In the first application, the retention times of peaks of interest are matched under different mobile phase conditions for the purpose of transferring the method from a mass spectrometry (MS) unfriendly buffer to an MS friendly buffer. The second application includes developing a method for simultaneous detection and quantitation of degradants and aggregates in a biologics + small molecule combination product. The third application supports method development by confirming the purity of separated peaks using orthogonal columns in the first and second dimensions and can be was used to investigate mass balance issues where some peaks are expected to elute in the solvent front.

Item Type:	Article
Keywords:	Two-dimensional liquid chromatography, 2D-LC, Selective 2D-LC, Peak capacity, Pharmaceuticals, Peak purity, Hydrophobic subtraction model, Mass-balance issues, Large biomolecule drug, Small molecule drug
Date Deposited:	20 Mar 2018 00:45
Last Modified:	20 Mar 2018 00:45
URI:	https://oak.novartis.com/id/eprint/33362