Objective To establish a method for the determination of polymer content in bromfenac sodium eye drops.Methods A chromatographic column of Waters C18(4.6 mm×250 mm,5 μm)wasused.The column temperature was 30℃,mobile phase A was 0.05 mol/L potassium hydrogen phosphate solution(pH 4.5)-acetonitrile(75:25),mobile phase B was acetonitrile with gradient elution.The flow rate was 1.0 ml/min.The wavelength for detection was 400 nm.Results The polymer and adjacent impurity peaks could be effectively separated,and the linear range of the bromfenac sodium peak was 0.1-10.0 μg/ml(r=0.9995),the detection limit was 0.02 μg/ml,and the quantification limit was 0.05 μg/ml.Conclusion The established quantitative method is simple and accurate and can be used for the quality control of polymers in bromfenac sodium eye drops.
维普
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