Analytical Method Development and Validation

One of the core strengths of the Centre is our ability to develop and validate both routine and novel analytical methodologies.  As an example of a routine development exercise, we can develop HPLC methods for API’s that will measure %w/w assay and impurity content as described by the ICH guidelines.

We can apply a number of different detection systems including -UV (VWD and PDA), -MSⁿ, RI, Fluorescence and ELSD. Typically, method development and validation will involve a number of steps that will start with optimising specificity, development of a stability indicating method with validation as appropriate (accuracy, precision (repeatability & reproducibility), range, linearity, robustness etc.).