建立HPLC法测定盐酸洛美沙星滴眼液中5种抑菌剂  

Establishment of an HPLC method for the determination of five kinds of antimicrobial agents in lomefloxacin hydrochloride eye drops

作　　者：逄焕欢[1] 高磊 杨志宏 冯艳春[3] Pang Huan-huan;Gao Lei;Yang Zhi-hong;Feng Yan-chun(Jilin Institute for Drug Control, Changchun 130033;Changchun Weiersai Biological Pharmaceutical Co., Ltd., Changchun 130033;National Institutes for Food and Drug Control, Beijing 102629)

机构地区：[1]吉林省药品检验所,长春130033 [2]长春卫尔赛生物药业有限公司,长春130033 [3]中国食品药品检定研究院,北京102629

出　　处：《中国抗生素杂志》2018年第6期709-714,共6页Chinese Journal of Antibiotics

摘　　要：目的建立同时测定盐酸洛美沙星滴眼液中5种抑菌剂(羟苯甲酯、羟苯乙酯、硫柳汞、苯扎溴铵和苯扎氯铵)的HPLC方法。方法采用Extend C18(4.6mm×250mm,5μm)色谱柱,流动相为1%三乙胺溶液(磷酸调p H值至3.0)-甲醇,梯度洗脱,流速为1.0m L/min,柱温35℃,检测波长为262nm。结果羟苯甲酯、羟苯乙酯、硫柳汞、苯扎溴铵/苯扎氯铵各峰均分离良好;羟苯甲酯在0.0410~0.8204mg/m L范围内线性关系良好(r=1.0000),平均回收率为100.2%(RSD=0.8%,n=9);羟苯乙酯在0.0400~0.7996mg/m L范围内线性关系良好(r=1.0000),平均回收率为100.3%(RSD=0.7%,n=9);硫柳汞在0.0806~1.6112mg/m L范围内线性关系良好(r=0.9995),平均回收率为100.8%(RSD=0.9%,n=9);苯扎溴铵在0.0204~0.4076mg/m L范围内线性关系良好(r=0.9998),平均回收率为100.0%(RSD=0.9%,n=9);苯扎氯铵0.0197~0.3932mg/m L范围内线性关系良好(r=1.0000),平均回收率为100.4%(RSD=1.0%,n=9)。结论该方法准确、灵敏、简便,可用于盐酸洛美沙星滴眼液中羟苯甲酯、羟苯乙酯、硫柳汞、苯扎溴铵及苯扎氯铵5种抑菌剂的检查。Objective To establish an HPLC method for the simultaneous determination of five kinds of antimicrobial agents （methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, mercurothiolate, benzalkonium bromide and benzalkonium chloride） in lomefloxacin hydrochloride eye drops. Methods The analysis was carried out using an extend C18 column （4.6mmx250mm, 5μm）. The mobile phase consisted of 1% triethylamine （adjusting pH to 3.0 with phosphoric acid） and methanol as the gradient elute. The flow rate was 1.0mL/min, the column temperature was 35℃and the detection wavelength was 262nm. Results The five kinds of antimicrobial agents were well separated. The linear range of methyl p-hydroxybenzoate was 0.0410-0.8204mg/mL （r=l.000）, and the average recovery was 100.2% （RSD=0.8%, n=9）. The linear range of ethyl p-hydroxybenzoate was 0.0400-0.7996mg/mL （r=1.000）, and the average recovery was 100.3% （RSD=0.7%, n=9）. The linear range of mercurothiolate was 0.0806-1.6112mg/mL （r=0.9995）, and the average recovery was 100.8% （RSD=0.9%, n=9）. The linear range of benzalkonium bromide was 0.0204-0.4076mg/mL （r=0.9998）, and the average recovery was 100.0% （RSD=0.9%, n=9）. The linear rangeof benzalkonium chloride was 0.0197-0.3932mg/mL （r=1.000）, and the average recovery was 100.4% （RSD=1.0%, n=9）. Conclusion The method is accurate, sensitive and simple, and it can be used for the determination of methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, mercurothiolate, benzalkonium bromide, benzalkonium chloride in lomefloxacin hydrochloride eye drops.

关 键 词：HPLC法 盐酸洛美沙星滴眼液 抑菌剂 羟苯甲酯 羟苯乙酯 硫柳汞 苯扎溴铵 苯扎氯铵 

分 类 号：R987.1[医药卫生—药品]