反相高效液相色谱法测定蜂地麻滴眼液的含量

Determine of the Fengdima eye drops by RP-HPLCC

目的:建立RP-HPLC法测定蜂地麻滴眼液中盐酸丁卡因和盐酸麻黄碱含量的方法。方法:采用梯度洗脱反相高效液相法;C_(18)色谱柱;以0.05 mol/L磷酸二氢钠:乙腈=9:1为流动相A,0.05mol/L磷酸二氢钠:乙腈=3:7为流动相B;检测波长:218 mm。结果:盐酸丁卡因和盐酸麻黄碱在50.26～753.9μg/mL和51.38～770.7μg/mL范围内线性良好(r=1.000、0.9995),平均回收率为100.25%、99.57%,RSD为0.75%、0.91%(n=9)。结论:该方法可有效地同时测定样品中盐酸丁卡因和盐酸麻黄碱的含量,简便准确,适用于有蜂蜜干扰的制剂的含量测定。

Objective：To establish a RP-HPLC method for determining the contents of tetracaine hydrochloride and ephedrine hydrochloride in Fengdima eye drops. Methods： A gradient elution RP-HPLC method was used with a Clscolumn（4.6 mm × 250 mm, 5um） ,the mobile phase consisted of 0.05 mol/L sodium dihydrogen phosphate-acetonitril （9 ： 1, for A pump） and 0.05 mol/L sodium dihydrogen phosphate buffer-acetonitril （3 ： 7, for B pump） ;the determination wavelength was 218 nm. Results ：The determination was not interfered by the excipient. The linear range of tetracaine hydrochloride was 50.26 - 753.9 ug/mL, r = 1. 000. The linear range of ephedrine hydrochloride was 51.38 - 770.7 ug/mL, r = 0. 999 5. The average recovery were 100.25% ,99.57% respectively, while RSD were 0.75% ,0.91% , respectively. Conclusion：The contents of tetracaine hydrochloride and ephedrine hydrochloride could be determined effectively at the same time by the proposed method, which is simple, accurate and can be applied for determining the contents of preparation interfered by honey.