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DOI: 10.1055/s-0031-1274875
Evaluating Transferability of Methods between LC Instrumentation Technologies
Many methods existing today in compendia and internal SOPs were developed on instrumentation dating back as far as 20 years ago. The more commonly used legacy, High Performance LC (HPLC) instruments were generally quaternary low pressure mixing systems. As column technologies evolved to smaller particle sizes, the key to harnessing the theoretical benefits of smaller particles resides in the physical aspects related to reducing system and extra-column volume. As a result, LC instrumentation has evolved to reduce such band broadening effects in the form of „Ultra-performance“ LC (UPLC). Today's technology provides chemists with the system performance and flexibility to aid method transfer of legacy methodology. Although these advances in LC technology are tremendous for the advancement of chromatographic science, the implication of fostering the new technology for routine applications becomes a challenge. Direct transfer of these methods to the newer technology may result in retention time and selectivity differences that may be related to decreases of system volume, different implementations of temperature control, or gradient mixing mechanisms used by today's instrumentation. As a result, method transfer has been considered labor intensive, challenging and expensive. The pharmaceutical industry realizes the benefits of adopting today's instrumentation; however, the instrumentation must be able to provide a dual purpose of performing legacy methods and sub-2µm methodology in their QA/QC environment without complications for increased asset utilization. In this presentation, various compendial methods are used as examples highlighting a new method transfer calculator to facilitate the transfer of methods to and from any LC-based instrumentation with ease.