高效液相色谱法测定盐酸丁卡因滴眼液中两组分含量

Determination of Two Components in Tetracaine Hydrochloride Eye Drops by HPLC

目的建立同时测定盐酸丁卡因滴眼液中盐酸丁卡因和羟苯乙酯含量的高效液相色谱法。方法采用Kromasil C18色谱柱(250mm×4.6mm,5μm),流动相为甲醇-水-三乙胺-冰醋酸(65:35:0.5:0.2),流速为1.0mL/min,检测波长为280nm。结果两组分完全分离,盐酸丁卡因和羟苯乙酯质量浓度线性范围分别是4.16～104.00μg/mL(r=0.9999)和0.1196～2.9900μg/mL(r=0.9998),平均回收率分别为100.89%和101.61%,RSD分别为0.58%和0.90%(n=9)。结论高效液相色谱法操作简便,结果准确,重现性好,可用于盐酸丁卡因滴眼液的质量控制。

Objective To establish a method for simultaneous determination of two components in Tetracaine Hydrochloride Eye Drops by HPLC. Methods HPLC was performed with Cls column （250 mm × 4. 6 mm, 5 μm） and the mobile phase consisted of methanol - water - triethylamine-glacial acetic acid （65：35：0. 5：0. 2）, at the flow rate of 1. 0mL/min. The UV detective wavelength was 280 nm. Results Two components could be separated completely. The linear range of tetracaine hydrochloride and ethylparaben were well shown within 4. 16- 104. 00 μg/mL （ r = 0. 999 9） and 0. 119 6 - 2. 990 0 μg/mL（ r = 0. 999 8） respectively. The average recovery rates were 100.89% and 101.61% with the RSD 0. 58% and 0. 90% respectively（ n =9）. Conclusion The method is simply operated with accurate and reliable results. It is available for the quality control of the production of Tetracaine Hydrochloride Eye Drops.