A general approach to method development based on the concept of quality by design is described. The work flow includes problem definition, mode selection, selectivity optimization, system optimization, and method validation. Computer-assisted methods can support some of these decision steps minimizing the time required to build a robust method. The approach used is generally applicable but practical illustrations will largely be restricted to isocratic and gradient elution methods in reversed-phase liquid chromatography. Critical parameters are identified as column selection, identification of the mobile phase composition, gradient time, temperature, pH (for ionizable compounds), and buffer concentration. We focus on how to select these variables and their influence on the quality criteria for defining method suitability.
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