Selecting a Suitable LC Column for Pharmaceutical Separations using a Column Characterisation System

Abstract

Selecting a reversed phase liquid chromatographic (RP-LC) column with suitable selectivity for a particular separation is difficult if the brand name of the column is not known. Monographs of the European Pharmacopoeia and other official compendia for drug analysis only give a general description of the stationary phase to be used for a liquid chromatographic method. A project to develop a chromatographic test procedure to characterise RP-LC C₁₈ columns was started earlier and resulted in a fast, simple, repeatable, and reproducible test procedure. Four column parameters allowed the characterisation and ranking of these columns. In this paper, the separations of three drug substances (amlodipine, tetracaine, and bisacodyl) from their respective impurities were examined applied on 77 RP-LC columns. It was observed, that the column ranking system was helpful in the selection of a suitable column for the separation of amlodipineand tetracaine, but also showed its limitations towards the separation of bisacodyl.

Keywords:

• Amlodipine
• Bisacodyl
• Chromatographic tests
• Column ranking
• Tetracaine

ACKNOWLEDGMENTS

The authors thank the European Pharmacopoeia for the generous gift of the investigated drugs and impurities and the manufacturers, as well as the suppliers for the gift of columns.

E. Farkas thanks the Ministry of the Flemish Community for financial support. E. Adams is a post-doctoral fellow of the Fund for Scientific Research (FWO) – Flanders, Belgium.

Financial support to this project is given by a Research Grant of the Fund for Scientific Research-Flanders (Belgium).

Manuscript 6403