The Future of HPLC-Method Development: Quality by Design - Evaluating the Control Space of Robust HPLC Method

Arranged and presided over by Imre Molnar of the Molnar-Institute for Applied Chromatography, Monday afternoon’s “The Future of HPLC-Method Development: Quality by Design — Evaluating the Control Space of Robust HPLC Methods” focused on the role of method robustness and quality by design in maintaining the high quality of pharmaceutical and chemical products that are distributed worldwide. Following the introductory remarks by Imre Molnar, Loren Wrisley presented “Quality by Design: Separation Robustness.”

Next up was LCGC’s own John W. Dolan, who discussed “Taking Advantage of Column Selectivity with Computer-Aided HPLC Method Development” along with colleagues Thomas H. Jupille and Lloyd R. Snyder. They focused on how to take advantage of a currently available column selectivity database to help select alternate columns for HPLC method development. This was followed by Karthik Jayaraman, Frank Hu, Frank P. Tomasella, and Merill Davies with “A Stepwise Strategy for Developing a Robust HPLC Separation for a Novel Diabetes Compound.”

There was no scheduled recess during this session, and the presentations continued with “Software’s Role in Ongoing Chromatographic Method Design,” which was delivered by Mike McBrien, Vadim Tashlitsky, and Andrey Vazhentsev. It was interesting to hear about processes and tools that incorporate experimental design principles, chemometric data extraction for LC–MS and LC–UV hyphenated traces, chromatographic modeling, and automation, while enabling the update of the decision-making system when new impurities arise.

The final presentation in this session was given by Imre Molnar and Hans-Jurgen Rieger. Entitled “Robust Methods in HPLC — Evaluating the Limits of the Settings of Chromatographic Parameters,” it was an appropriate conclusion to this informative session.