RAPID UPLC METHOD FOR ESTIMATION OF BROMFENAC AND APPLICATION TO EYE DROPS

摘要

Objectives: New stability-indicating reverse phase UPLC method developed and validated for the estimation of Bromfenac and successfully applied for the estimation of it in commercially available eye drops. Methods: The chromatographic conditions were optimized using the samples generated from forced degradation studies. The chromatographic separation was achieved on C18 UPLC column. The method employed a linear gradient elution and the detection wavelength was set at 230 nm. The mobile phases consists of buffer and acetonitrile delivered at a flow rate of 0.5 mL·min–1. Proposed method was extensively validated as per ICH guidelines. Results: Regression analysis shows an r value (correlation coefficient) of greater than 0.999 for individual active drug substances. The samples were assayed against a qualified reference standard and the mass balance was found to be close to 98.3%. Conclusion: The developed method is also stability-indicating and can be used for the routine analysis of bromfenac crude drug and also check the purity and stability of the active substance in marketed eye drops