高效凝胶色谱法测定角膜接触镜护理液中泊洛沙姆含量  

Determination of poloxamer in contact lens care solution by high performance gel chromatography

作　　者：文燕[1] 张莉[1] 陈靖云[1] 何涛[1] 王敏珠[1] 

机构地区：[1]国家食品药品监督管理局杭州医疗器械质监督检验中心,杭州310009

出　　处：《药物分析杂志》2014年第10期1751-1754,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：浙江省科技厅计划项目(2015F30010)

摘　　要：目的：建立高效凝胶色谱法测定角膜接触镜护理液中有效成分泊洛沙姆含量。方法：选择市场上含有泊洛沙姆的角膜接触镜多功能护理液及润滑液,以水凝胶色谱柱Shodex OHpak（SB 802.5）为分离柱,柱温30℃,流动相为磷酸二氢钠溶液（0.02 mol·L-1）-乙腈（7∶3）,流速0.7 mL·min-1;示差折光检测器测定。结果：分析显示泊洛沙姆在浓度0.2~3.0 mg·mL-1范围内线性良好,标准曲线为Y=1.025×104X＋1.261×104（r=0.9993）;精密度试验（n=6）的RSD为1.1%之间;通过标准加入法测定泊洛沙姆的平均回收率在97%~103%之间。结论：建立的高效凝胶色谱法经方法学验证,可作为隐形眼镜护理液及润滑液中有效成分泊洛沙姆质量控制的方法之一。Objective ： To determine the content of poloxamer in contact lens care solution by high performance gel chromatography（HPGCG） method. Methods：The commercial contact lens care solutions which contained poloxamer were selected for the study. The Shodex OHpak （ SB 802.5 ） column was used, using acetonitrile and water with the ratio of 7 ： 3 （ containing 0.02 tool ~ L - 1 sodium dihydrogen phosphate） as the mobile phase and 0.7 mL · min-f as the flow rate. The RI Shimadzu RID -2A detector was used for determination. Results：The analysis showed poloxamer had good linearity at concentrations of 0.2 - 3.0 mg· mL-1 , the standard curve was Y = 1. 025 × 104X ＋ 1. 261 × 104, with correlation coefficient r = 0. 9993. The precision experiment（ n = 6） showed RSD of poloxamer was measured to be 1. 1%. The standard addition recovery of poloxamer ranged from 97% to 103%. Conclusion： HPGCG is a convenient, stable and reliable method, and may serve as a mass control method for the content of nonionic surfactant poloxamer in contact lens care solution.

关 键 词：角膜接触镜护理液 泊洛沙姆 非离子表面活性剂 高效凝胶色谱法 

分 类 号：R917[医药卫生—药物分析学]