Stability Behaviour of Antihypertensive Drugs and their Combination with Genotoxicity Study of Degradation Products

Abstract

Quality Assurance mainly focused on the quality, safety, purity, and efficacy of drugs and pharmaceuticals. Pharmaceutical Analysis is mainly focused on qualitative and quantitative analysis of pharmaceuticals. Identity, purity, physical characteristics, and potency of drugs and drug products are determined using various analytical techniques. Numerous impurities may be produced as a result of API degradation and/or other storage-related interactions. Stability studies must therefore be carried out to anticipate, analyse, and ensure the safety of pharmaceutical products. Fixed dose drug combinations with multiple active pharmaceuticals increase the risk of stability issues. The knowledge of origin, source, and nature of impurities or degradation products, can be used to control them during drug synthesis and product development. It can be a challenging task to identify and detect all impurities or degradants formed during stability studies. Therefore, performing in silico drug degradation prediction prior to the stability study can provide valuable information about degradants and help maximize understanding of the degradation pathway. In this regard, the drug degradation prediction tools helps to predict the stability of new and existing chemicals. The prediction of the toxicity of formed degradation products was an important aspect of chemical safety assessment and risk management. To predict the toxicity of degradation products, various methods and tools can used and these methods can help to identify potential hazardous properties of degradation products, such as mutagenicity, carcinogenicity, and toxicity to specific organs or systems.The formation of degradation products is not only limited to, drug excipients interaction, and drug applied chemical exposure interaction, but also there may be the possibility of formation of degradation products of drug-drug incompatibility.