Drug Development and Analysis Review

摘要

The drug discovery has now evolved into a much more scientific and rational process due to better understanding of biological processes and the underlying chemistry, owing to the progress made due to advances in high throughput experimental techniques and availability of high performance computation resources. The process has matured to the stage where drugs are designed rather than being discovered. The development and validation of analytical methods play important roles in the discovery, development, and manufacture of pharmaceuticals. Method development is the process of proving that an analytical technique is acceptable for use to measure the concentration of an active pharmaceutical ingredient (API) in a particular compound dosage form. This allows simplified procedures to verify that a proposed analytical method will accurately and consistently perform reliable measurements of APIs in a given drug preparation. The validation of analytical method is essential for its development, whereby it is extensively tested for specificity, linearity, accuracy, precision, range, limit of detection, limit of quantitation, and robustness. Thus, the development and validation of analytical methods allows one to confirm that accurate and reliable measurement of the potency a pharmaceutical preparation can be performed. The present review highlights the process of drug development, its phases, and analytical methods, including chromatographic, spectroscopic, and electrochemical techniques, which have been applied in the analysis of pharmaceuticals.