ABSTRACT
This chapter describes the validation of analytical methods for marketed drug products in the pharmaceutical industry, as this approach to method validation can be considered the most comprehensive. Instrument performance contributes to the accuracy of the analytical method. The system suitability tests for chromatographic methods are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. The chromatographic method should be specific and sensitive, as required, for all known relevant degradation products and/or impurities. In the pharmaceutical industry, a sample matrix may include impurities, degradation products, excess raw materials, or excipients. The response of the analyte in a solution containing all impurities, degradation products, and/or excess raw materials is compared with the response of the solution containing only the analyte. Specificity was demonstrated by spiking known process impurities into a standard solution and verifying that each impurity was separated from the main peak.
