| 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) |
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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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