摘要
目的建立HPLC测定盐酸左氧氟沙星滴眼液中防腐剂羟苯乙酯含量的方法。方法以十八烷硅烷基键合硅胶为填充剂;以0.005 mol/L醋酸铵溶液(每1 000 mL含三乙胺10 mL,用冰醋酸调pH 5.0)-乙腈(50︰50)为流动相;检测波长256 nm;流速1.0 mL/min;柱温35℃。结果羟苯乙酯在0.017 7～0.041 3 mg/mL范围内呈良好的线性关系(r=0.999 97)。平均回收率100.4%(n=9),RSD=0.97%。结论此法简便、快速、准确,可有效控制产品质量。
Objective To establish an HPLC method for the determination of ethylparaben in Levofloxacin Hydrochloride Eye Drops.Methods An ODS column was used with 0.005 moL/L ammonium acetate（10 mL triethylamine in 1 000 mL solution adjusted to pH 5.0 with glacial acetic acid）-acetonitrile（50：50）as the mobile phase.The detection wavelength was 256 nm and the flow rate was 1.0 mL/min.The column temperature was kept at 35 ℃.Results The calibration curve of ethyl hydroxybenzoate was linear in the concentration range of 0.017 7-0.041 3 mg/mL（r= 0.999 97）.The average recovery was 100.4 %（n = 9,RSD = 0.97 %）.Conclusion The method is simple,rapid and accurate,and can be used for the quality control of Levofloxacin Hydrochloride Eye Drops.
出处
《食品与药品》
CAS
2010年第9期326-328,共3页
Food and Drug
