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1、中國(guó)藥品標(biāo)準(zhǔn)2008年第9卷第1期62DrugStandardsofChina2008,vol9No1HPLC法測(cè)定羥苯甲、乙、丙、丁酯中的有關(guān)物質(zhì)1112袁耀佐,錢文,黃敏文,賀霞(1江蘇省藥品檢驗(yàn)所,南京210008;2伊梨州藥品檢驗(yàn)所,伊梨835000)摘要目的:建立快速、準(zhǔn)確的高效液相色譜法(HPLC)測(cè)定羥苯甲、乙、丙、丁酯中的有關(guān)物質(zhì)。方法:采用C18柱,流動(dòng)相為-1甲醇-1%的冰醋酸(6040),流速為10mLmin,檢測(cè)波長(zhǎng)254nm。結(jié)果:羥苯甲、乙、丙、丁酯的自身對(duì)照溶液在各供試品溶液025%~4%濃度范圍內(nèi)呈線性,對(duì)羥基
2、苯甲酸、羥苯甲酯、羥苯乙酯、羥苯丙酯、羥苯丁酯的檢測(cè)限分別為05065,04935,04900,04975,05430ng,5組分之間的校正因子均在08~13范圍內(nèi),5組分的響應(yīng)因子(峰面積/供試品的濃度,Y)與其化學(xué)結(jié)構(gòu)側(cè)鏈上含碳數(shù)(n)成正比,Y=-00727n+12179E-09,r=09932。結(jié)論:該方法簡(jiǎn)單、快捷,靈敏度高,同時(shí)適用于羥苯甲、乙、丙、丁酯有關(guān)物質(zhì)的測(cè)定。關(guān)鍵詞:HPLC;有關(guān)物質(zhì):羥苯甲酯羥苯乙酯羥苯丙酯羥苯丁酯中圖分類號(hào):9212文獻(xiàn)標(biāo)識(shí)碼:A文章編號(hào):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羥苯甲、乙、丙、丁酯在化妝品、食品以及藥物制水楊酸,考慮到水楊酸是本品合成原料中可能劑中廣泛用作抗菌防腐劑,美國(guó)藥典、歐洲藥典、日引入的雜質(zhì),在原料質(zhì)量標(biāo)準(zhǔn)中已有控制,且經(jīng)檢[1-3]本藥局方對(duì)他們的
8、質(zhì)量標(biāo)準(zhǔn)均有收載,中國(guó)藥