应用离子对hplcelsd法测定磷霉素钠中磷霉

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1、应用离子对HPLCELSD法测定磷霉素钠中磷霉【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Fosfomycinis

2、asynthetic,broadspectrumbactericidalantibioticfororaladministration.IthasinvitroactivityagainstapositiveandGramnegativeaerobicmicroorganisms,ycinhasnoUVVisabsorptionhasledtothedevelopmentoffeethodsforitsdetermination.Asfarasethod,i.e.theBritishPharmacopo

3、eia(BP)methodusedforanalysisoffosfomycintrometamol［2a］canprovideseparationforfosfomycinandrelatedsubstances.DuetothepoorsensitivityofRIdetector,verylargeamountofsampleisinjectedycinpeaktobebroadened,andtheresolutionbetycinandrelatedsubstancesmightbereduced.F

4、urthermore,duetothepoorbuffercapacityofthemobilephaseandleaststabilityoftheNH2column,theBPmethodisnotrobustenough.AccordingtoBP［2b］,fosfomycinsodiumanddisodium1,2(dihydroxypropyl)phosphonate(diolsubstance)aredeterminedbytitrimetricmethodacopoeia(ChP)method［

5、3a］,fosfomycininfosfomycinsodiumisdeterminedbymicrobiologicalanalysis,ycinsodiumdiolsubstancesaredeterminedbytitrimetricmethod.ThisarticleprovidedanionpairHPLCELSDmethodforthedeterminationoffosfomycinandrelatedsubstancesinfosfomycinsodium.　　1Experiment1.1M

6、aterialsFosfomycinsodiumandfosfomycincalciumaceuticalsCo.,Ltd.FosfomycinChineseNationalChemicalReferenceStandard(CRS)ofactivity651μg/mg,fosfomycintrometamolEuropeanPharmacopoeiaCRSofactivity53.1%,andfosfomycintrometamolimpurityA(diolsubstance)EuropeanPhar

7、macopoeiaCRSineAldrich.AcetontrileE.Merck.AllotherchemicalsentationTheelutioned.ASedex75evaporativelightscatteringdetectorobilephasecontained0.015mol/Loctylaminesolution(adjustedtopH5.2aintainedat1.5ml/min.Chromatographicseparationsedat35℃ona250mm×4.6mmi.d.

8、columnpackedLuna5μC18(2)andtheinjectionvolumeperature45℃,thegain8andthepressureofair0.35MPa.1.4SolutionpreparationA0.97mg/mlfosfomycintrometamolCRSstocksolutionobilephaseandstoredlightintherefri