HPLC法测定溴芬酸钠滴眼液中聚合物的含量

Determination of polymer content in bromfenac sodium eye drops by HPLC

目的建立溴芬酸钠滴眼液中聚合物的含量测定方法。方法采用色谱柱Waters C_(18)(4.6 mm×250 mm,5μm),柱温30℃,流动相A为0.05 mol/L磷酸氢二钾溶液(pH 4.5)-乙腈(75∶25),流动相B为乙腈,梯度洗脱,流速1.0 ml/min,检测波长400 nm。结果聚合物与相邻杂质峰可以有效分离,溴芬酸钠峰的线性范围为0.1~10.0μg/ml(r=0.9995),检出限为0.02μg/ml,定量限为0.05μg/ml。结论建立的含量测定方法简便、准确,可用于溴芬酸钠滴眼液中聚合物的质量控制。

Objective To establish a method for the determination of polymer content in bromfenac sodium eye drops.Methods A chromatographic column of Waters C_(18)(4.6 mm×250 mm,5μm)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 0.1-10.0μg/ml(r=0.9995),the detection limit was 0.02μg/ml,and the quantification limit was 0.05μg/ml.Conclusion The established quantitative method is simple and accurate and can be used for the quality control of polymers in bromfena c sodium eye drops.