应用离子对hplcelsd法测定磷霉素钠中磷霉素及有关物质的含量

《应用离子对hplcelsd法测定磷霉素钠中磷霉素及有关物质的含量》由会员上传分享，免费在线阅读，更多相关内容在应用文档-天天文库。

1、应用离子对HPLCELSD法测定磷霉素钠中磷霉素及有关物质的含量【摘要】建立了HPLCELSD法测定磷霉素钠中磷霉素及有关物质的含量。采用ODS柱，柱温35℃，以0.015mol/L正辛胺溶液(用冰乙酸调节pH至5.2)∶乙腈(90∶10)为流动相，蒸发光散射检测器温度为45℃，雾化气体压力为0.35MPa。磷霉素及其二醇物分别在26.0～207.7和7.6～60.6μg/ml范围内呈良好的线性关系，两者的定量限分别为8.7和7.7μg/ml。【关键词】离子对HPLCELSD含量测定磷霉素钠有关物质Fosfomycinisasynthet

2、ic,broadspectrumbactericidalantibioticfororaladministration.IthasinvitroactivityagainstapositiveandGramnegativeaerobicmicroorganisms,ycinhasnoUVVisabsorptionhasledtothedevelopmentoffeethodsforitsdetermination.Asfarasethod,i.e.theBritishPharmacopoEia(BP)methodusedforanaly

3、sisoffosfomycintrometamol［2a］canprovideseparationforfosfomycinandrelatedsubstances.DuetothepoorsensitivityofRIdetector,verylargeamountofsampleisinjectedycinpeaktobebroadened,andtheresolutionbetycinandrelatedsubstancesmightbereduced.Furthermore,duetothepoorbuffercapacityofthe

4、mobilephaseandleaststabilityoftheNH2column,theBPmethodisnotrobustenough.AccordingtoBP［2b］,fosfomycinsodiumanddisodium1,2(dihydroxypropyl)phosphonate(diolsubstance)aredeterminedbytitrimetricmethodacopoEIa(ChP)method［3a］,fosfomycininfosfomycinsodiumisdeterminedbymicrobiologic

5、alanalysis,ycinsodiumdiolsubstancesaredeterminedbytitrimetricmethod.ThisarticleprovidedanionpairHPLCELSDmethodforthedeterminationoffosfomycinandrelatedsubstancesinfosfomycinsodium.　　1Experiment1.1MaterialsFosfomycinsodiumandfosfomycincalciumaceuticalsCo.,Ltd.FosfomycinChi

6、neseNationalChemicalReferenceStandard(CRS)ofactivity651μg/mg,fosfomycintrometamolEuropeanPharmacopoeiaCRSofactivity53.1%,andfosfomycintrometamolimpurityA(diolsubstance)EuropeanPharmacopoeiaCRSineAldrich.AcetontrileE.Merck.AllotherchemicalsentationTheelutioned.ASedex75evapo

7、rativelightscatteringdetectorobilephasecontained0.015mol/Loctylaminesolution(adjustedtopH5.2aintainedat1.5ml/min.Chromatographicseparationsedat35℃ona250mm×4.6mmi.d.columnpackedLuna5μC18(2)andtheinjectionvolumeperature45℃,thegain8andthepressureofair0.35MPa.1.4Solutionprepara

8、tionA0.97mg/mlfosfomycintrometamolCRSstocksolutionobilephaseandstoredlighti