Two simple, rapid and sensitive spectrophotometric methods were developed for the determination of Fluorometholone in pharmaceutical formulations in methanol (Method A) and Octane sulfonic acid buffer (pH 3.0) (Method B). Beer’s law was obeyed over the concentration range 0.1-80 µg/mL in both methods. The linear regression equations were found to be y = 0.040x + 0.005 and y = 0.040x - 0.013 in Method A and B respectively. The % RSD was found to be 0.76 and 0.97 in Method A as well as 0.58 and 0.49 in Method B for intra-day and inter-day precision studies. The % RSD in accuracy studies was also found to be less than 2.0. The proposed methods are simple and suitable for the determination of Fluorometholone in pharmaceutical formulations. No interferences were observed from the excipients in the formulations. The methods were validated according to ICH guidelines.
Fluorometholone, Eye drops, Validation