高效液相色谱法测定诺氟沙星滴眼液中羟苯甲酯、羟苯乙酯、羟苯丙酯含量

Content Determination of Methylparaben,Ethylparaben,Propylparaben in Norfloxacin Eye Drops by HPLC

目的建立同时测定诺氟沙星滴眼液中羟苯甲酯、羟苯乙酯、羟苯丙酯含量的高效液相色谱(HPLC)法。方法色谱柱采用Phenomenex Gemini C_(18)柱(250 mm×4.6 mm,5μm),流动相为1%冰醋酸溶液-甲醇(50∶50),流速为1.0 mL/min,检测波长为255 nm,进样量为20μL,柱温为20℃。结果羟苯甲酯、羟苯乙酯、羟苯丙酯的质量浓度线性范围分别为0.99~44.50μg/mL,5.02~52.70μg/mL,1.05~41.64μg/mL,加样回收率分别为98.37%,97.19%,99.34%,RSD分别为1.34%,1.43%,0.80%(n=9)。结论该方法准确,专属性强,稳定,无干扰,可用于诺氟沙星滴眼液中抑菌剂的含量分析。

Objective To establish an HPLC method for determination of methylparaben, ethylparaben and propylparaben in Norfloxacin Eye Drops. Methods The Phenomenex Gemini C_（18） column（ 250 mm × 4. 6 mm,5 μm） was adopted,the mobile phase was 1% acetic acid-methanol（ 50 ∶ 50）,the flow rate was 1. 0 mL/min,the detection wavelength was 255 nm,the injection volume was 20 μL and the column temperature was 20 ℃. Results Methylparaben,ethylparaben and propylparaben showed good linear relationship in the range of 0. 99-44. 50 μg/mL,5. 02-52. 70 μg/m L,1. 05-41. 64 μg/mL. The average recovery rates were 98. 37%,97. 19%,99. 34%,respectively,the RSDs were 1. 34%,1. 43%,0. 80%（ n = 9）. Conclusion The method is accurate,reproducible and stable without interference,which can be used for the determination of bacteriostatic agent in Norfloxacin Eye Drops.