THE IMPORTANCE OF FORCED DEGRADATION STUDIES IN THE DEVELOPMENT OF STABILITY INDICATING METHODS FOR DRUG

Abstract

The modern development of validated stability indicating methods for active substances and drug products is of great importance in pharmaceutical analysis. The paper presents the mandatory stages of this development. The largest number of stability indicating methods are methods that are based on the application of high-performance liquid chromatography. Forced degradation studies are carried out on pure active substances and pharmaceutical forms in solid form, solutions or suspensions. These studies can be performed at different stages of drug development. Their goal is to examine the basic chemical stability of the active pharmaceutical substance and pharmaceutical dosage form, as well as to determine the internal stability of molecules by establishing clear degradation pathways, in order to identify degradation products and confirm stability. These studies determine the inherent stability characteristics of molecules, such as degradation pathways and mechanisms, and lead to the identification of degradation products. The detailed nature of the study depends on the individual active substance and type of drug. It is important to consider regulatory guidelines related to forced degradation studies, as well as experimental conditions for their performance, which should include testing for sensitivity to the effects of hydrolysis, oxidation, thermal degradation, moisture and light.