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1、中国药品标准2008年第9卷第1期62DrugStandardsofChina2008,vol9No1HPLC法测定羟苯甲、乙、丙、丁酯中的有关物质1112袁耀佐,钱文,黄敏文,贺霞(1江苏省药品检验所,南京210008;2伊梨州药品检验所,伊梨835000)摘要目的:建立快速、准确的高效液相色谱法(HPLC)测定羟苯甲、乙、丙、丁酯中的有关物质。方法:采用C18柱,流动相为-1甲醇-1%的冰醋酸(6040),流速为10mLmin,检测波长254nm。结果:羟苯甲、乙、丙、丁酯的自身对照溶液在各供试品溶液025%~4%浓度范围内呈线性,对羟基
2、苯甲酸、羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯的检测限分别为05065,04935,04900,04975,05430ng,5组分之间的校正因子均在08~13范围内,5组分的响应因子(峰面积/供试品的浓度,Y)与其化学结构侧链上含碳数(n)成正比,Y=-00727n+12179E-09,r=09932。结论:该方法简单、快捷,灵敏度高,同时适用于羟苯甲、乙、丙、丁酯有关物质的测定。关键词:HPLC;有关物质:羟苯甲酯羟苯乙酯羟苯丙酯羟苯丁酯中图分类号:9212文献标识码:A文章编号:1009-3656(2008)-1-62-4D
3、eterminationofRelatedSubstanceinMethylparaben,Ethylparaben,Propylparaben,Buth-ylparabenbyHPLC1112YuanYao-zuo,QianWen,HuangMin-wen,HeXia(1JiangsuProvincialInstituteforDrugControl,Nanjing210008;2YiliStateInstituteforDrugControl,Yili835000)AbstractObjective:Toestablisharapidandaccur
4、atemethodfordeterminingrelatedsubstanceinmethylparaben,ethylparaben,propylparaben,buthylparabenbyHPLCMethods:AC18Columnwasused,themobilephasewasmethol-1%glacidaceticacid(60-140),theflowratewas10mLmin,thedetectivewavelengthwas254nmResults:Thecalibrationcurvesofmethylparaben,eth-y
5、lparaben,propylparaben,buthylparabenwereallingoodlinearityovertherangeof025%~4%testingsolutionconcentration,thelimitofdetectionof4-hydroxybenzoicacid,methylparaben,ethylparaben,propylparaben,buthylparabenwere05065,04935,04900,04975,05430ng,respectively,thecorrectionfactorsamong
6、themwerebetween08~13,theresponsefactor(areaofmainpeak/concentrationofeachcomponent,Y)ofthemisdirectproportionaltothenumberofcarbonintheirsidechain(n),theregres-sionequationwasY=-00727n+12179E-09,r=09932Conclusion:thismethodissimple,rapidandsensitive,itissuitabletothedeterminati
7、onofrelatedsubstanceinmethylparaben,ethylparaben,propylparabenandbuthylparaben,simultaneouslyKeywordsHPLC;RelatedSubstance;Methylparabe;Ethylparaben;Propylparaben;Buthylparaben羟苯甲、乙、丙、丁酯在化妆品、食品以及药物制水杨酸,考虑到水杨酸是本品合成原料中可能剂中广泛用作抗菌防腐剂,美国药典、欧洲药典、日引入的杂质,在原料质量标准中已有控制,且经检[1-3]本药局方对他们的
8、质量标准均有收载,中国药
