Analytical issues in the chemical stability testing of drugs in solution

Abstract

The pharmaceutical analyst is primarily involved in drug stability studies as he or she must develop a suitable method that will quantitate the drug in the presence of degradation products, impurities and excipients. This article attempts to identify the issues that are critical in the development of an analytical method for the stability teting of drugs in solution. A short review of the analytical techniques used in stability tests is presented and the requirement for a stability indicating analytical method to carry out such tests is emphasized. A brief discussion on reaction kinetics in relation to stability tests is also included to provide some groundwork before discussing the practical issues.