Applications of Ion Chromatography in the Pharmaceutical/Biotech Industry

While in its earliest embodiment ion chromatography (IC) was primarily used for the analysis of inorganic anions, today IC plays an important role in the analysis of organic ions as well as inorganic ions. For the majority of applications, suppressed conductivity detection represents the most versatile detection system complemented by a variety of other detection modes such as UV/Vis, all forms of amperometric detection, and element-specific (IC‒ICP) and mass-selective detection (IC‒MS).

Ion chromatography can contribute to the characterization of pharmaceutically relevant compounds, especially at a very early stage of drug development. This includes trace analysis of impurities and metabolites, elemental analysis, structural identification of counter ions, analysis of water used in pharmaceutical formulations and the analysis of ionic drugs. Typical inorganic and organic counter ions of pharmaceutical drug components can be determined in the same run and very sensitively by means of IC utilizing suppressed conductivity detection. Alternatively, pharmaceutically relevant counter ions can also be separated on mixed-mode stationary phases, supporting ion-exchange and hydrophobic interactions. Trimodal stationary phases support cation-exchange, anion-exchange, and reversed-phase interactions and thus allow the simultaneous analysis of active pharmaceutical ingredients (APIs) and their counter ions. Taking substituted bisphosphonic acids as an example, it will be shown that IC can also be used for analyzing ionic drugs together with their respective metabolites. Because those compounds do not have any chromophores, suppressed conductivity is again the detection method of choice.

Integrated pulsed amperometry allows sensitive detection of native carbohydrates. The simplicity of direct detection with sub-pmol detection limits makes it applicable to a wide range of applications including therapeutic protein characterization and vaccine analysis. In addition, this technique offers on-line monitoring and process optimization capabilities for large-scale cell cultures and fermentation broths used in the production of protein- and peptide-based therapeutics.

Presenter: Joachim Weiss (Technical Director, Thermo Fisher Scientific)

Dr. Joachim Weiss started his professional career in 1982 as an applications chemist at Dionex Corporation in Germany. He currently holds the position of International Technical Director for the chromatography commercial organization at Thermo Fisher Scientific. He is renowned for his exceptional knowledge in separation science and is a recognized authority on Thermo Scientific™ IC and HPLC instrumentation and applications.