The changing face of pharmaceutical analysis

The author outlines the changes in the field of pharmaceutical analysis in the past 25 years. The most remarkable development has been the introduction and rapid spread of high-performance liquid chromatography. This technique has become the most important method in the quality control of bulk drugs and pharmaceutical formulations, even at the pharmacopoeial level, and (increasingly coupled with mass spectrometry) also in the determination of drugs and metabolites in biological samples. The changes in the role of other chromatographic (electrophoretic) and spectroscopic techniques are also discussed with emphasis on their hyphenated variants. There are separate sections devoted to chiral issues and regulatory aspects of drug analysis with emphasis on questions related to validation.