Stress testing

In this article forced degradation is a degradation of drug product and new drug substance at different condition more severe accelerated condition. The forced degradation studies ensure chemical behavior of the molecule which in turn helps the development of formulation and packaging. The HPLC is an essential analytical tool in assessing drug and product stability. It insists various conditions like humidity, temperature, light and environmental factors which may affects the drug substance and drug product.

Ramipril is a prodrug of the active metabolite ramiprilat, it inhibits angiotensin-converting enzyme and consequent raise in blood pressure. Its pharmacologic effect aids the treatment of hypertension, congestive heart failure and reduces mortality in post myocardial infarction patients. As for other drugs, Ramipril might degrade upon storage and compromise the quality, efficacy and safety of the product. In order to avoid deterioration, it is important to characterize the degradation products and source of stress (temperature, water content, oxidizers, etc). This review aims to summarize the data concerning the subject and serve as a guide for further studies.