ESTUDO DE ESTABILIDADE DO FOSFATO DISSÓDICO DE PREDNISOLONA EM CONDIÇÕES DE ESTRESSE OXIDATIVO E TÉRMICO, EM FORMULAÇÃO ORAL

Abstract

This work was to investigate the process of degradation of the drug Prednisolone Sodium Phosphate (FSP) in oral solution dosage form through the degradation experiments, evaluating the parameters in accordance with Resolution 899/2003 ANVISA and the degradation process of the drug. The method by high performance liquid chromatography (HPLC) developed for the determination of the drug was validated to demonstrate its applicability as an indicator of stability, ensuring reliability. After the method be validated to study the degradation of the drug, it was shown that drastic conditions of oxidative stress (H O 30%) and 2 2 temperature 60°C, the degradation of the drug is dependent on its concentration (first order kinetics). The results were satisfactory, showing that this method is suitable to investigate the formation of degradation products in oral dosage form solution