Stability indicating stress degradation studies for bilastine

Abstract

Studies on forced degradation involve the breakdown of novel pharmacological substances. These investigations demonstrate the molecule's chemical stability, which makes it easier to prepare stable formulations with proper storage conditions. Since the chemistry of each substance differ, the experimental technique for carrying out forced degradation experiments will rely on the active components and formulation involved. It is generally advised to aim for degradation rate of 20% or less. According to ICH recommendations, some factors might cause degradation, such as UV light, oxidation, dry heat, acidic or basic conditions, Humidity, etc. The forced deterioration experiments are clearly illustrated by ICH Q1A, QIB, and Q2B. The mobile phase, which was Buffer (2.72 g Potassium dihydrogen orthophosphate dissolved in 1000 mL water adjust pH 2.40 with OPA) : Acetonitrile (600: 400) was delivered through the C-18 column in a gradient mode.