Analytical chemistry underpins pharmaceutical drug development by providing assurance of safety, efficacy and quality of a new medicine. The process of drug development starts with the discovery of a novel drug molecule, the API (active pharmaceutical ingredient). In the case of phyto-pharmaceuticals (herbal medicines) the API is not a single chemical substance but an herbal drug or extract thereof. This extract has regulatory and standardization requirements. Variations can be observed in an extensive pre-drug development including detailed analytical assessment of chemical profiles or in the specific requirements for the analytically guided pharmacological screening. In recent years, new instrumental and sample preparation methods i.e. solid-phase extraction techniques enabled a substantial progress in analytical characterization of complex herbal mixtures. Hence, by combination of "traditional" analytical techniques with state of the art instrumental methods, a new era of herbal drug development has started.
