Protocols for Developing and Testing Methods Applied to the Quality Control of Botanicals

Both the application of official/published methods and the development of a novel analytical protocol need specific guidelines for their validation. Methods developed for quality controls of botanicals could be classified as: (1) phytochemical assays, and DNA-based identification; (2) methods for the identification and quantification of specific compounds. The validation of the methods for phytochemical and DNA-based identification requires the following parameters: ruggedness, specificity and limit of detection (LOD). In relation to development and testing of methods for detection of specific compounds: beneficial and toxic substances, contaminants, residues and biomarkers, this chapter presents guidelines based on good analytical practices, to assist analyst in obtaining data of requested quality and to aid in the evaluation of the quality of obtained data. This chapter will be organized in the following three parts: (1) evaluation of the problem and characterization of analytical requirements; (2) development of methods; and (3) validation of methods. The parameters that have to be evaluated for in-house validation will be different depending on the type of method (qualitative or quantitative, compounds in high concentration or traces).