The objective of this investigation was to study the degradation behavior and kinetics of the difluprednate from ophthalmic emulsion under different ICH recommended stress condition by validated stability indicating LC method for quantification of potential known and unknown degradation product. Chromatographic separation was achieved on the C-18 stationary phase with a gradient elution using a mobile phase A consisting of ammonium formate (pH 4.5 ±005 adjusted with formic acid) and acetonitrile (ACN) as mobile phase B. The detection was carried out by UV-PDA detector at 240 nm with a flow rate of 1.5 ml/min and run time of 36 min. Developed RP-HPLC method was validated for accuracy (recovery), precision, linearity, specificity, robustness (deliberate change in pH, Flow rate and column oven temperature) and limit of detection and quantification in accordance with ICH guidelines (Q2 R1). To study the degradation behavior, difluprednate were subjected under hydrolysis (acidic and alkaline), oxidative, thermal and photolytic stress conditions. Degradation products were well resolved from the difluprednate. Moreover, the kinetics of the acid, alkaline, peroxide, thermal and photolytic degradation of the difluprednate was investigated. Different order of kinetic plots were constructed and found that zero order kinetic plots fits to calculate the degradation rate constant, half life and shelf life of difluprednate.
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