地塞米松磷酸钠滴眼液中两种抑菌剂的分析

Study on Two Bacteriostatics Agents in Dexamethasone Sodium Phosphate Eye Drops

目的探讨地塞米松磷酸钠滴眼液中所用抑菌剂的合理性及其含量测定方法。方法采用高效液相色谱法测定羟苯乙酯含量,色谱柱为Agilent Eclipse XDB-C18柱(150 mm×4.6 mm,5μm),流动相为三乙胺溶液(取三乙胺7.5 mL,加水至1 000 mL,用磷酸调pH至3.5±0.05)-甲醇-乙腈(55∶40∶5),检测波长为242 nm。结果羟苯乙酯质量浓度在3～300μg/mL范围内与峰面积线性关系良好,r=0.999 8(n=8);平均回收率为100.64%,RSD为0.80%(n=9)。结论羟苯乙酯含量测定方法准确、重现性好,适用于日常检验;硫柳汞钠作为处方中抑菌剂使用时,应注意与其他辅料成分的相互作用。

Objective To study two bacteriostatics agents in dexamethasone sodium phosphate eye drops,and establish an HPLC method for the determination of ethylparaben.Methods Using Agilent Eclipse XDB-C18 column（150 mm×4.6 mm,5 μm） to determination content of ethylparaben,triethylamine solution（taking triethylamine 7.5 mL,add water to 1 000 mL,with phosphoric acid to adjust pH value to 3.5±0.05）-methanol-acetonitrile（55：40：5） as the mobile phase,the detection wavelength is 242 nm.Results The linear range was 3～300 μg/mL,r=0.999 8（n=8）.The average recovery was 100.64%,RSD=0.80%（n=9）.Conclusion The method for determination content of ethylparaben is accurate and reproducible for routine testing.Thimerosal as a bacteriostatic agent used in the prescription should pay attention to the interaction with other excipients.