Stability studies for the determination of shelf life of aceclofenac formulation

摘要

Stability studies for optimized formulations were carried out according to ICH guidelines.The optimized formulations were subjected to accelerated stability studies [1]. Sufficient replicates of formulation were prepared, packed in aluminium foil and stored in petri dishes at temperature of 40± 0.5°C, 50± 0.5°C and 60± 0.5°C for 60 days. Samples were withdrawn at intervals of 15, 45 and 60 days and analyzed for drug content by HPLC method. The shelf life of formulations of aceclofenac were determined by accelerated stability studies on the basis of first order degradation kinetics and t0.9 (the time required to degrade 10 % of drug at 25°C). The shelf life was found to be 1.469 yrs.