4.2.12. Accelerated Stability Study According to ICH Q1A (R2) Guidelines

A stability investigation was performed on the optimized RUT-loaded GM liquid formulation and gel formulation to evaluate whether there will be any physical or chemical changes during storage. The formulation was stored for 3 months in a Borosil amber-colored glass container at 40 ± 2 °C, 75 ± 5%RH and 4 ± 0.5 °C for a stability assessment. Following storage, samples were obtained at 0-day, 1 week, 2 weeks, 1 month, 2 months, and 3 months intervals. Various parameters such vesicle size, PDI, % entrapment efficiency, physical appearance, color, phase separation, clarity, pH, homogeneity and washability were then used to determine the stability [39].