High‐performance liquid chromatography (HPLC), particularly Reversed Phase HPLC (RP‐HPLC), is the most important analytical technique in the pharmaceutical industry. In method development, during validation, transfer or out of specification studies, a traditional approach may fail. This article describes how statistically QbD principles can be used for each phase of LC instrument method development. A Quality by Design (QbD) approach to method development make the use of Statistical design of experiments (DoE) for the development of a robust method ‘design space’. To understand the factors and their interaction effects by a desired set of experiments is an important component in QbD. In this approach, first the requirement for a method is defined. There will be understanding of what the method has to measure and requirement for the method Based on the critical material, process and product attributes. The previous knowledge can be helpful in identifying initial conditions. A design space is identified followed by a screening study. The resulting data are utilised for analysis to generate a resolution response surface to identify potential optimum chromatographic conditions.
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