反相高效液相色谱法测定酮咯酸氨丁三醇滴眼液的含量

目的 采用反相高效液相色谱法测定酮咯酸氨丁三醇滴眼液的含量.方法 采用RP-HPLC法,色谱柱为C8柱(4.6mm×250 mm,5μm)；流动相为磷酸盐缓冲液-四氢呋喃(70 ∶ 30)；流速为1.2 mL·min-1；检测波长313 nm.结果 酮咯酸氧丁三醇在0.24～0.56 mg·mL-1 (r=0.999 7)与峰面积呈良好线性关系,其平均回收率为100.3％,RSD=0.34％(n=9);仪器精密度RSD=0.23％(n=6)；方法重复性RSD=0.43％(n=6).结论 该分析方法灵敏、准确,专属性强,重现性好,可以作为酮咯酸氨丁三醇滴眼液的质量控制方法.

RP-HPLC determination of content of ketorolac tromethamine in ketorolac tromethamine eye drops

Objective To determine the content of ketorolac tromethamine in ketorolac tromethamine eye drops.Methods Reversed phase HPLC system was performed on a C8 column(4.6 mm×250 mm,5 μm),with the mixture of phosphate buffer-tetrahydrofuran =70∶30 as the mobile phase at 1 mL·min-1.The absorbance was monitored at 313 nm.Results The linear response range was 0.24-0.56 mg·mL-1(r=0.999 7).The average recovery of ketorolac tromethamine was 100.3%.RSD of the precision was 0.23%(n=6) and that of the repeatability was 0.43%(n=6).Conclusion The method is sensitive,accurate,specific and repeatable,and can be used in the quality control of ketorolac tromethamine eye drops.