依诺沙星滴眼液中防腐剂含量的测定

Determination of preservatives in enoxacin eye drops

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。

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.