Stability Profiling of Amodiaquine under stress Degradation Conditions

Abstract

Degradation Product is an impurity which results from a chemical change in the drug substance during storage and/or manufacture of the new drug product due to some environmental changes or by reaction with an excipient and/or the immediate container closure system. Impurity development may be either during formulation or upon aging of both API’S and formulated API’S in medicines. The objective of the current investigation was to study the stress degradation behaviour of Amodiaquine under different ICH recommended stress conditions by HPLC method. The anti-malarial drug Amodiaquine, when subjected to stress degradation conditions of hydrolysis, oxidation, photolysis and thermal decomposition prescribed by ICH guideline Q1A (R2), it is found that, the drug Amodiaquine (API) was stable. The method was established using column C18 Hypersyl BDS (250* 4.6) mm, 5µ, mobile phase as monobasic potassium phosphate PH 2.5 with orthophosphoric acid and methanol. Method was isocratic and composition 22: 78 (A: B), at a flow rate of 1.2ml/ min. To facilitate the development of analytical methodology, in order to obtain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and also to provide information about degradation pathways and degradation products, this process is very useful. These types of studies will provide information about the degradation products that could form during storage and transportation.