托吡卡胺滴眼液中主成分及防腐剂的含量检测

目的 建立同时测定托吡卡胺滴眼液中主成分托吡卡胺和防腐剂羟苯甲酯、羟苯乙酯含量的HPLC方法.方法 采用Agilent Eclipse XDB C18色谱柱,流动相为5 mmol·L^-1醋酸铵溶液（用冰醋酸调节pH值至5.5）-乙腈（70：30）,流速为0.8 mL·min^-1,检测波长为256 nm,柱温为30℃.结果 托吡卡胺、羟苯甲酯和羟苯乙酯分别在49.87～748.05、5.31～106.2和5.03～100.7 μg·mL^-1范围内线性关系良好（r≥0.9998）,平均回收率分别为100.0％、101.2％和99.5％,RSD分别为1.0％、0.7％和1.0％（n=9）.结论 本法经方法学验证可用于托吡卡胺滴眼液中托吡卡胺、羟苯甲酯和羟苯乙酯含量的测定.

Determination of Main Ingredients and Preservatives in Tropicamide Eye Drops

Objective To establish an HPLC method for the determination of tropicamide, methylparaben and ethylparaben in Tropicamide Eye Drops. Methods An Agilent Eclipse XDB C18 column was used with 5 mmol · L^-1 ammonium acetate （adjusted to pH 5.5 with glacial acetic acid） -acetonitrile （70 ： 30） as the mobile phase at a flow rate of 0.8 mL ·min^-1. The detection wavelength was 256 nm and the column temperature was 30 ℃. Results The linear ranges of tropicamide, methylparaben and ethylparaben were 49.87-748.05, 5.31-106.2 and 5.03-100.7 μg·mL^-1（r≥0. 9998）, respectively. The average recoveries were 100.0%, 101.2% and 99.5%, and RSDs were 1.0%, 0.7% and 1.0
%, respectively （n= 9）. Conclusion The proposed method is simple, practical and accurate, which can be used for the determination of tropicamide, methylparaben and ethylparaben in Tropicamide Eye Drops.