Outlining the key steps to analytical method development

Thought and foresight into method development stages can ensure costly errors and delays are avoided later. Method development is a critical and continuous process that, if optimised, ensures successful progression of a drug product through its life cycle to commercialisation.

There are several key elements when it comes to method development, and it is crucial to get it right for a successful drug development programme.

It is crucial to collect as much background information as possible on the API to understand its characteristics or what development challenges it poses

Developers need to select an appropriate solvent system for dissolving a sample. They should also choose a suitable separation mode, such as reversed phase chromatography or Hydrophilic Interaction Chromatography (HILIC). A detection principle should also be chosen – for example, for UV or visible light, detection wavelength should be selected. UV detection is preferred if the analytes contain a UV chromophore due to the widespread availability of UV detectors in QC laboratories.

In an article with Pharm Tech, our Analytical Chemist Anders Mörtberg, discusses the key stages to method development.

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