高效液相色谱法测定消旋山莨菪碱滴眼液中抑菌剂含量

Content Determination of Bacteriosatic Agents in Raceanisodamine Eye Drops by HPLC

目的建立同时测定消旋山莨菪碱滴眼液中2种抑菌剂羟苯乙酯、苯扎溴铵含量的高效液相色谱法(HPLC)法。方法色谱柱采用Aglient Zorbax Eclipse Plus C18柱(250 mm×4. 6 mm,5μm),流动相为1%三乙胺溶液(用磷酸调p H至3. 0)-甲醇,梯度洗脱,流速为1. 0 m L/min,检测波长为210 nm,进样量为10μL,柱温为30℃。结果羟苯乙酯、苯扎溴铵的峰面积与质量浓度的线性关系良好(r> 0. 999),线性范围分别为1. 07~106. 80μg/m L和5. 45~545. 00μg/m L,加样回收率分别为99. 15%,98. 07%,RSD分别为1. 05%和1. 25%(n=9)。结论该方法准确,专属性强,稳定且无干扰,可用于消旋山莨菪碱滴眼液中抑菌剂的含量分析。

Objective To establish an HPLC method for content determination of two bacteriosatic agents（ethylparaben and benzalkonium bromide） in Raceanisodamine Eye Drops. Methods The chromatographic column was Aglient Zorbax Eclipse Plus C18 column（250 mm× 4.6 mm, 5 μm）, the mobile phase was 1% triehtylamine（adjusted pH to 3.0 with phosphoric acid）-methanol, gradient elution, the flow rate was 1.0 mL/min, the detection wavelength was 210 30℃. Results Ethylparaben and benzalkonium bromide showed column temperature was 1.07 - 106. 80 pog/mL, 5.45-545.00 txg/mL（r 〉 0.999）.The average recovery rates were 99. 15% and 98.07%, RSDs were 1.05% and 1.25% （n=9）. Conclusion The method is accurate, reproducible, stable with no interference, which can be used for content determination of bacte- riosatic agents in Raceanisodamine Eye Drops.