A Quality-by-Design Methodology for Rapid LC Method Development, Part III

Joseph Turpin, Patrick H. Lukulay, and Richard Verseput Quality-by-design (QbD) is a methodology that enables the practitioner to obtain quantitative process knowledge efficiently. When applied to liquid chromatography (LC) method development work, the LC instrument system is the process; and quantitative definition of how controllable instrument parameters affect chromatographic performance is the knowledge. This threepart series describes a QbD approach to the rapid development of robust LC methods. This approach provides quantitative process knowledge that can be used to identify the LC instrument parameter settings that provide optimum chromatographic performance, including method robustness. Most importantly, this knowledge can support the analyst's ability to modify the LC method as required to maintain acceptable performance.