Method validation is an important activity for pharmaceutical evaluations to ensure that analytical methods are suitable for their intended use. With particular focus on active ingredient and impurities, the implementation of different categories of method validation are explained for qualitative and quantitative methods. Detailed explanations with example approaches are provided for the key aspects of method validation, namely specificity, accuracy, linearity, limits of detection/quantitation, precision, robustness, and method range. While all of the sections outlined for method validation are generally applicable for a variety of techniques commonly used in pharmaceutical analysis (i.e., UV and HPLC instrumentation), focused attention is provided for examples that have been implemented using high performance thin layer chromatographic techniques.
Part of the book: Calibration and Validation of Analytical Methods