Analytical methods for drugs in the next decade.

Today's research for new drug substances is moving toward molecules of much larger molecular weight and complexity than the small, modern drug molecules, e.g., polypeptides, interferon, slow-releasing substances, and blood and plasma components. The complexity of natural products derived from human or other animal bodies requires a new analytical chemistry. Simple tests for drug stability, dissolution, and bioavailability will no longer suffice to provide and ensure purity and structural identity of such drugs. During the next decade, the demands on analytical chemists will increase; more biological organic and physical chemistry will be required by analysts to perform their jobs. Criteria for purity will require even greater chromatographic involvement but this will have to be complemented by nuclear magnetic resonance and mass spectrometry. The demands made on AOAC to validate and approve methods to assay drugs and determine their purity will increase enormously in this next decade. The understanding of drug purity will take on a new meaning because of the complex nature of natural products. Stability indication will be significant only when chemical and biological tests can complement and define the active components and the impurities. AOAC will be required to play a major role in assuring the manufacturer and the public that their drugs are adequately tested, safe, and efficacious.