普拉洛芬滴眼液中防腐剂苯扎氯铵的含量测定

Determination of Preservative Benzalkonium Chloride Content in Pranoprofen Eys Drops by HPLC

目的:建立普拉洛芬滴眼液中防腐剂苯扎氯铵的含量测定方法。方法:采用Diamonsil C18色谱柱,规格为4.6×250mm,粒度为5μm,以0.02mol/L庚烷磺酸钠溶液(含0.1%三乙胺,用磷酸调节pH值3.45±0.1)-乙腈(35∶65)为流动相;流速为1.5ml/min;检测波长208nm;柱温:40℃。结果:苯扎氯铵中的C12含量最高,C14和C16达不到检测限,且C12色谱峰与普拉洛芬峰及空白辅料峰均能达到有效分离。结论:选择条件显示HPLC法具有灵敏、准确、重现性好,可有效测定普拉洛芬滴眼液中防腐剂苯扎氯铵的含量。

Objective：A HPLC method for determination of preservatives Benzalkonium Chloride in Pranoprofen Eye Drops was established.Methods：A C18 column（4.6×250mm,5μm） was used with the mobile phase of 0.02mol/L Heptane sulfonate solution（0.1% Triethylamine adjusted pH to 3.45±0.1 with phosphoric acid） -acetonitrile（35∶65） ,at the detectionwavelength of 208nm,at the flow of 1.5ml/min and the column temperture of 40℃.Results：The content of C12 in the Benzalkonium chloride was the highest,and the contents of C14 and C16 in the Benzalkonium chloride didn＇t reach the limit of detection.The peaks of C12,Pranoprofen and blank materials can achieve an effective separation.Conclusion：The HPLC method showed a sensitive,accurate,reproducible and can be effective in the determination content of preservatives benzalkonium chloride in Pranoprofen eye drops.