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机构地区:[1]中国石油天然气集团公司中心医院药学部,河北廊坊065000 [2]河北医科大学药学院,河北石家庄050017
出 处:《分析科学学报》2016年第5期729-732,共4页Journal of Analytical Science
摘 要:建立了分析含有高分子辅料的凝胶类制剂中活性成分的中空纤维离心超滤前处理方法,并结合高效液相色谱法(HPLC)测定双氯芬酸钠凝胶含量。凝胶样品经中空纤维离心装置纯化,滤除样品中高分子辅料,采用HPLC法测定双氯芬酸钠凝胶的含量。经聚偏氟乙烯中空纤维膜对样品进行超滤处理,有效去除了高分子凝胶辅料的干扰。实验采用Phenomenexc C18柱,流动相为甲醇-0.1%乙酸溶液(体积比85∶15),检测波长为276nm。双氯芬酸钠在5.10~30.6μg·mL^(-1)范围内呈良好的线性关系(r=0.9998)。样品平均回收率为99.8%,相对标准偏差不大于1.6%。所建立的方法简便、快速,定量准确,可用于双氯芬酸钠凝胶的含量测定。A sample pretreatment method based on hollow fiber centrifugal ultrafiltration has been developed for the analysis of the active components in gels containing polymer materials.The procedure combined with high performance liquid chromatography(HPLC)was applied to the content analysis of diclofenac sodium gel.The gel samples were purified by hollow fiber centrifugal ultrafiltration technique and determined by HPLC after the macromolecule gel materials were removed.The results showed that the polymer gel materials were effectively removed from the sample solutions ultrafiltrated with the PVDF hollow fiber membrane.It was carried out on a C18 reversed phase column with the mobile phase of methanol-0.1% acetic acid solution(85∶15).The UV detection wavelength was 276 nm.There was a good linearity within the concentration range of 5.10-30.6μg·mL^-1(r=0.9998).The average recovery was 99.8%.The precision(RSD)was less than 1.6%.This method is simple,rapid,accurate,and applicable for the determination of diclofenac sodium in gel.
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