Chemical stability of prednisone oral suspension and drug substance

Abstract

An accelerated chemical stability study of Prednisone oral suspension has been performed during 6 months. A stability indicating chromatographic method was developed and validated according to the ICH guidelines by reversed phase using a Chromolith® C-18e monolithic column 4.6 x 100 mm, water:tetrahydrofuran:methanol 73:23:4 v/v/v as mobile phase, UV detection at 243 nm and 1 mL/min flow rate. Prednisolone was used as internal standard. Prednisone drug substance was subjected to forced degradation by acid and basic hydrolysis and oxidation condition, UV-Vis radiation effect, temperature and relative humidity were studied to demonstrate the indicating capability of the chromatographic method. Two and five degradation products were detected at acid and basic forced degradation respectively. No degradation products were detected at the others studied conditions. One degradation product from Prednisone oral suspension was detected during the accelerated chemical stability study. The proposed method was adequate to determine Prednisone drug substance, Prednisone oral suspension and their degradation products. The kinetic parameters of Prednisone oral suspension under the studied conditions are also reported.