Development of Stability Indicating Methods

The evaluation of the chemical stability studies of small molecule pharmaceuticals rely primarily on the availability of a chromatographic or other separation assay capable of separating and quantifying major impurities and degradation products. A staged approach to the development of stability-indicating HPLC methods, consistent with current regulatory guidelines, is outlined. Practical recommendations are provided for developing forced degradation protocols at every stage of drug development and avoiding common pitfalls that may confuse data interpretation. Consideration is given to special cases such as stereoisomeric drugs, polymorphs, and combination drug products.