依诺沙星滴眼液中防腐剂含量的测定

目的建立依诺沙星滴眼液中常用防腐剂苯扎溴铵、苯扎氯铵和羟苯乙酯的HPLC含量测定方法。方法采用C18柱,苯扎溴铵和苯扎氯铵以0.005mol/L的醋酸铵溶液(每1L中含三乙胺10mL,用冰醋酸调节pH值至5.0±0.5)-乙腈(40∶60)为流动相,检测波长214nm,进样量为50μL;羟苯乙酯以0.005mol/L的醋酸铵溶液(每1L中含三乙胺10mL,用冰醋酸调节pH值至5.0±0.5)-乙腈(50∶50)为流动相,检测波长256nm,进样量20μL。结果苯扎溴铵、苯扎氯铵和羟苯乙酯在各自线性范围内呈良好的线性关系,r分别为0.9998、0.9998、0.9999;平均回收率分别为100.6%、100.0%、100.2%(n=9)。结论该方法简单、准确,适用于依诺沙星滴眼液中三种常用防腐剂苯扎溴铵、苯扎氯铵和羟苯乙酯的含量测定。

Determination of preservatives in enoxacin eye drops

Objective To establish a quantitative analysis of benzalkonium bromide,benzalkonium chloride and ethylparaben in enoxacin eye drops by HPLC.Methods The determination was performed on a C18 column,the mobile phase of benzalkonium bromide and benzalkonium chloride was a mixture of 5mmol/L ammonium acetate(10mL triehtylamine in 1L solution adjusted to pH5.0 with glacial acetic acid) and acetonitrile(40:60),the wavelength was 214nm;the mobile phase of ethylparaben was a mixture of 5mmol/L ammonium acetate(10mL triehtylamine in 1L solution adjusted to pH5.0 with glacial acetic acid) and acetonitrile(50:50),the wavelength was 256nm.Results The standard curves of benzalkonium bromide,benzalkonium chloride and ethylparaben were linear(r=0.9998,0.9998,0.9999).The average recoveries were 100.6%,100.0%,100.2%(n=9).Conclusion The method is simple,accurate,and suitable for the determination of benzalkonium bromide,benzalkonium chloride and ethylparaben in enoxacin eye drops by HPLC.