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Part 1: A Quality-by-Design Methodology for Rapid LC Method Development

    Part 1:  A Quality-by-Design Methodology for Rapid LC Method Development

    This installment of Validation Viewpoint describes how statistically rigorous quality-by-design (QbD) principles can be put into practice to accelerate each phase of liquid chromatography (LC) instrument method development. Here, in Part I, the authors examine the current approaches to column screening in terms of design space coverage — a key element of process knowledge. The second part presents novel data treatments to both accelerate and bring quantitation to the column-screening effort. The third installment will focus on integrating quantitative method robustness estimation into formal method development. Moving robustness estimation upstream into the method development effort is consistent with both FDA and ICH guidances. It also enables the identification of instrument methods that simultaneously meet both mean performance and performance robustness requirements.

    Development of analytical methods for LC instrument systems typically is carried out in two phases. The first phase involves column screening, sometimes referred to as column scouting. Column screening is the experimental work done to identify the analytical column (stationary phase) with the best selectivity in terms of all compounds in the sample that must be resolved adequately. Formal method development, the second phase, involves experimenting with additional instrument parameters believed to affect compound separation strongly. The overall goal of the two phases is identification of the instrument parameter settings that provide optimum chromatographic performance.

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