文章摘要
钱保勇.HPLC法测定滴眼液中5种常用抑菌剂的含量[J].中国药品标准,2023,24(1):
HPLC法测定滴眼液中5种常用抑菌剂的含量
Determination of five Bacteriostatic Agents in Eye Drops by HPLC
投稿时间:2022-07-02  修订日期:2023-01-30
DOI:
中文关键词: 滴眼液  抑菌剂  梯度洗脱  高效液相色谱法  含量测定
英文关键词: Eye drops  Bacteriostatic agents  Gradient elution  HPLC  Content determination
基金项目:泰州市科技支撑计划社会发展项目(项目编号SSF20190200)
作者单位E-mail
钱保勇* 泰州市药品检验院 114778266@qq.com 
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中文摘要:
      目的:建立HPLC法测定滴眼液中5种抑菌剂。方法:采用Waters SunFire C18色谱柱(250mm×4.6mm,5μm),以1%三乙胺溶液(用磷酸调节pH值至3.0)-甲醇为流动相,梯度洗脱,流速为1.0mL.min-1,测定波长为214nm和262nm。结果:5种抑菌剂可完全分离,线性关系均良好,相关系数r均大于0.999,重复性、精密度、稳定性RSD值均小于1%,回收率为98%~105%,RSD为1.2%~4.2%。结论:该方法准确、灵敏,专属性强,可作为滴眼液中常用抑菌剂的控制方法。
英文摘要:
      ABSTRACT Objective:To establish a method for the determination of five bacteriostatic agents in eye drops by HPLC.Methods:The analysis was performed on a Waters SunFire C18 column (250mm×4.6mm, 5μm) and the mobile phase consisted of 1% triethylamine solution (adjust pH to 3.0 with phosphoric acid) -methanol with gradient elution at a flow rate of 1.0mL?min-1. The detection wavelength were 214nm and 262nm.Result:The five bacteriostatic agents could be completely separated and showed good regression with the correlation coefficient more than 0.999. The RSD of repeatability,precision and stability were less than 1%. The mean recoveries were 98%~105% with the RSD of 1.2%~4.2%.Conclusions:The method is accurate,sensitive and reproducible for the determination of bacteriostatic agents in eye drops.
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