Published Paper Details:

Stability of drug substance or drug product is an essential parameter which can affect purity, potency and safety of the drug. Poor stability, impurities and toxic degradants is associated with poor efficacy, low potency and toxic effects of the drug product during treatment. So a need to establish shelf life, purity profile and chemical behavior of the drug substance under various different conditions(adjusted pH, temperature, humidity, light etc.) to determine better modifications during development and formulation of the drug. Forced degradation study involves exposure of drug substance to exaggerated conditions to establish chemical behavior of the drug substance or drug products; it is required to perform the study according to regulatory guidelines, at almost every stage of drug development. Forced degradation studies are useful to mimic decomposition of drug substance or drug product in real time stability studies, determine specificity of stability indicating method, the degradation pathways and degradation products likely to form during drug management (handling, storage and use) i.e drug stability profile. Stability indicating analytical procedures of different methods (such as: RP-HPLC, column chromatography and other spectroscopic techniques) are applied to analyze the outcomes of forced degradation conditions on drug substance which gives the qualitative and quantitative data analysis, which can be a combination of conventional and spectroscopic techniques. In this review we provide an insight about current trends on conducting forced degradation studies for stability indicating method.