Module 3 2019

Early Method Development Approach - HPLC

• Inspect route and decide what intermediates/impurities need to be separated (and what’s available)

• Simple solution stress experiment (acid/base/photo/peroxide/thermal)

• Mix impurities/intermediates and stressed solutions together

• Development/Validation cocktail

• Choose starting point – could be a generic method with known column and mobile phase stability • Use predictive/optimisation approaches to get all components of the cocktail separated

• Re-inject to check cocktail chromatogram matches predictions

• The final method suitable for early use with proven selectivity and developed from a starting point of proven performance

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