A Roundtable Discussion on LC Approaches for the Analysis of Kinase Inhibitors and Related APIs

Small molecule pharmacology has expanded into multiple exciting areas. In particular, a new pipeline of cancer-fighting drug candidates has emerged, and many of these molecules take aim at kinases as their druggable target. These molecules are built upon peptide mimicking backbones and are thereby constructed with heteroatoms and conjugated substituents that look similar to naturally occurring amino acid residues. Drug candidates within this pharmaceutical space are chemically unique, and there is an ever-present need for high-resolution impurity analyses.

We have recently worked on techniques for imatinib, one of the first kinase inhibitors to be approved in 2001, and we would like to host a technology forum with other scientists working in this field. With our recent work, we have taken advantage of charged surface hybrid phenyl columns and MS-compatible mobile phases to achieve significantly higher separation efficiency and selectivity for Imatinib and nine of its related impurities. This work provides new insights on chromatographic method development as well as ideas for modernizing and future proofing approaches with MS compatibility in mind.

During this round table, we would like to share information on:

• Accessing different chromatographic selectivity
• Mobile phase compositions and considerations with MS compatibility in mind
• The utility of MaxPeak HPS column hardware for certain types of analytes and impurities
• Serial detection by UV-MS for impurity quantitation and elucidation
• Q & A Session
• Conclusion

Moderator: Matt Lauber (Sr Principal Consulting Scientist, Research & Development, Waters Corporation)

Presenter: Peng Chen (Principal Scientist, Research & Development, Waters Corporation)