Study of forced degradation behavior of fluorometholone by reversed-phase high-performance liquid chromatography

Abstract

Introduction: The present proposed work describes the development and validation of a new liquid chromatographic method for the determination of fluorometholone (FM) in pharmaceutical products. Materials and Methods: Chromatography was performed on Shimadzu Model CBM-20A/20 Alite with C8 Phenomenex column (250 mm × 4.6 mm i.d., 5 μm particle size) using 0.1 M ammonium formate and methanol as mobile phase (flow rate 0.8 ml/min) (ultraviolet detection at 241 nm). Results and Discussion: The method was validated. The linear regression equation was found to be y = 35,207x + 29,529 (R² = 0.9995). FM was exposed to forced degradation conditions - acidic, alkaline, and thermal and oxidation stress conditions - and found that the drug is highly resistant. Conclusion: The proposed method was found to be robust and specific and can be used for the assay of FM.