加替沙星滴眼液有关物质的测定  

Determination of related substances in gatifloxacin eye drops by HPLC

作　　者：逯海龙 范蕊[2] 孙英华[2] 

机构地区：[1]宁夏食品药品审评认证中心,宁夏银川750001 [2]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2016年第11期883-888,共6页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立测定加替沙星滴眼液有关物质的HPLC方法。方法色谱柱为C18(250 mm×4.6 mm,5μm);以乙腈-磷酸盐缓冲液(体积比为16∶84)为流动相A,以乙腈-甲醇-磷酸盐缓冲液(体积比为20∶10∶70)为流动相B,检测波长为240 nm和285 nm;柱温:38℃。结果加替沙星与各有关物质均能得到良好分离,有关物质1-10的平均回收率分别为100.2%(RSD=1.06%)、101.7%(RSD=0.62%)、98.3%(RSD=0.82%)、100.4%(RSD=0.98%)、100.4%(RSD=1.16%)、101.9%(RSD=0.70%)、100.4%(RSD=0.73%)、99.3%(RSD=0.90%)、99.7%(RSD=1.12%)和99.9%(RSD=0.81%)。结论该方法可用于加替沙星滴眼液有关物质的测定。Objective To establish an HPLC method for the determination of related substances in gatifloxacin eye drops. Methods A C18 column （250 mm ×4. 6 mm,5 μm） was adopted,the mobile phase A was acetonitrile-phosphate buffer（ V： V = 16： 84）, the mobile phase B was acetonitrile-methanol-phosphate buffer （ V： V： V =20： 10：70） ,The column temperature was 38 ℃and the wavelength was set at 240 nm and 285 nm. Results Gatifloxacin and its related substances were completely separated. The average recoveries of related substances 1,2,3,4,5,6,7,8,9 and 10 were 100. 2% （RSD = 1.06% ） ,101.7% （RSD =0. 62% ）, 98.3% （RSD =0. 82%） ,100.4% （RSD =0. 98%） ,100.4% （RSD = 1.16%） ,101.9% （RSD =0.70%）, 100. 4% （RSD =0. 73% ） ,99.3% （RSD =0. 90% ） ,99.7% （RSD = 1.12% ）and 99.9% （RSD =0. 81% ） , respectively. Conclusions A specific and sensitive method is developed for the determination of related substances in gatifloxacin eye drops.

关 键 词：加替沙星滴眼液 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]