Stability Indicating Degradation Behaviour of Artesunate Under stress conditions
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Forced degradation is a method in which the drug compounds exposed to extreme chemical and environmental conditions to find out product breakdown levels and degradation kinetics, of potential degradation products. This process is useful to facilitate the development of analytical methodology, to obtain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. In addition to develop stability-indicating analytical methods, these kind of studies also provide information about the degradation products that could form during storage and transportation of API and drug products. Degradation Product is an impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system. Forced degradation studies also facilitate pharmaceutical development, in areas such as formulation, manufacturing, and packaging, in which knowledge of chemical behavior can be used to improve a drug product. Anti-malarial drug Artesunate was subjected to stress conditions of hydrolysis (acid and alkali), thermal and aqueous degradations. The degradation products were observed for Artesunate under hydrolytic acid degradation only, while it was found stable to remaining other stress conditions. The method was established using column C18 Hypersyl BDS (250* 4.6) mm, 5μ, mobile phase as buffer Potassium dihydrogen phosphate and acetonitrile and method composition 58: 42 (A: B), at a flow rate of 1ml/min. The isolation of impurities was carried out by Preparative HPLC. Anti-malarial drug Artesunate was subjected to stress degradation conditions prescribed by ICH guide line Q1A(R2).
Artesunate, Forced degradation, Hydrolysis, Stability, API.