HPLC同时测定盐酸萘甲唑啉滴鼻液中9种抑菌剂  

Simultaneous Determination of 9 Bacteriostats in Naphazoline Hydrochloride Nasal Drops by HPLC

作　　者：杨园 谷亦平 李苗 陈闪闪 童颖 YANG Yan;GU Yiping;LI Miao;CHEN Shanshan;TONG Ying(Wuhan Institute For Drug and Medical Device Control,Wuhan 430075,China;School of Pharmacy,Hubei University of Science and Technology,Xianning 437100,China)

机构地区：[1]武汉药品医疗器械检验所,武汉430075 [2]湖北科技学院药学院,湖北咸宁437100

出　　处：《中国现代应用药学》2019年第20期2552-2556,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：湖北省食品药品监督管理局科研项目(201601017)

摘　　要：目的建立HPLC同时测定盐酸萘甲唑啉滴鼻液中4类9种常见抑菌剂硫柳汞、羟苯乙酯、苯甲酸钠、羟苯甲酯、羟苯丙酯、羟苯丁酯、山梨酸钾、苯扎氯铵和苯扎溴铵的含量。方法采用Ultimate XB-C18(4.6 nm×250 nm,5μm)色谱柱;以乙腈(A)-0.1 mol·L^-1磷酸二氢钠(磷酸调pH 3.7)为流动相,梯度洗脱,流速1.0 mL·min^-1,柱温35℃,检测波长222 nm,样品温度5℃。结果9种抑菌剂可完全分离,平均回收率为98.2%~100.6%,RSD为0.5%~1.5%。30批样品中检出硫柳汞、羟苯乙酯、苯扎溴铵和苯甲酸钠4种抑菌剂。结论该法可用于盐酸萘甲唑啉滴鼻液中抑菌剂的质量控制。OBJECTIVE To establish an HPLC method for simultaneous determination of 4 categories and 9 species common bacteriostats which might be added into naphazoline hydrochloride nasal drops,including thimerosal,ethylparaben,sodium benzoate,methylparaben,propylparaben,butylparaben,sorbic acid,benzalkonium chloride,benzalkonium bromide.METHODS The analysis was performed on Ultimate XB-C18 column(4.6 mm×250 mm,5μm)at 35℃,eluted with a gradient program using acetonitrile(A)-0.1 mol·L^-1 sodium phosphate monobasic(pH was adjusted to 3.7 with phosphoric acid)as the mobile phase.The flow rate was 1.0 mL·min^-1,the detection wavelength was 222 nm,and sample was stored at 5℃.RESULTS Under the above conditions,9 bacteriostats were separated completely.The average recoveries of the 9 components were between 98.2%-100.6%,with RSDs of 0.5%-1.5%.The contents of thimerosal,benzalkonium bromide,ethylparaben and sodium benzoate were detected in 30 batches of naphazoline hydrochloride nasal drops.CONCLUSION The method is suitable to evaluate the quality of bacteriostats in naphazoline hydrochloride nasal drops.

关 键 词：抑菌剂 硫柳汞 苯扎溴铵 羟苯乙酯 苯甲酸钠 盐酸萘甲唑啉滴鼻液 鼻用制剂 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]