Accelerated Stability Studies of Atorvastatin Loaded Nanoemulsion Gel

Accelerated stability studies were carried out according to ICHQ1A (R2) guidelines. For drug products intended to be stored at room temperature, the accelerated stability studies are to be carried out at controlled temperature and humidity conditions of 40 ± 2°C and humidity 75 ± 5% RH. Results from stability studies indicated stability of atorvastatin loaded nanoemulsion gel formulation, as there was no significant change in observed physical parameters. The shelf life of nanoemulsion gel was found to be 19.23 months. The study conducted therefore substantiated the stability of atorvastatin loaded nanoemulsion gel.