Method Development Strategies

The approach to method development will be partly determined by the purpose of the method and the constraints upon it. An important factor is whether the method is required for long term use or for short term problem solving. Methods which are intended for long term use must be designed with robustness and validation in mind. Another important consideration is the sample matrix. Samples of a pure drug substance in water for example are easier to analyse than those in complex biological matrices. Samples in matrices such as blood may require extraction and purification before analysis is possible. High ionic strength matrices in particular can be especially problematic.