Stability studies on analytical solutions in a pharmaceutical laboratory

Abstract

Quality of pharmaceutical products, as defined by the ICH, is the suitability of either the drug product or the active pharmaceutical ingredient (API) for its intended application. In achieving quality, appropriate monitoring of products, systems and processes is put into practice during manufacture to establish satisfactory conformity to the finished product specifications prior to release. Method validation is carried out in order to demonstrate that analytical procedures are scientifically sound and suitable for their intended applications. Validation and suitability of the analytical procedures utilised in monitoring of the various stages of the production system are thus important in assuring accuracy and reliability of analytical results. Robustness, which is one of the validation characteristics tested during method validation, is a measure of the ability of an analytical procedure to remain unchanged by small but deliberate changes in the analytical parameters and provides an indication of the reliability of the procedure during routine application. In the case of liquid chromatography analytical procedures, one of the analytical parameters identified as subject to variation is the stability of analytical solutions. The data gathered from the determination of the stability of analytical solutions serves to set the range of analytical conditions under which the validity of the analytical procedure is maintained. These analytical conditions include the time between solution preparation and analysis and the conditions of storage.