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_论文

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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/L正辛胺溶液(用冰乙酸调节pH至)∶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。磷霉素及其二醇物分别在～和～μg/ml范围内呈良好的线性关系，两者的定量限分别为和μg/ml。【关键词】离子对HPLCELSD含量测定磷霉素钠有关物质Fosfomycinisasynthetic,broadspectrumbactericidalantibioticfororaladmini

2、stration.IthasinvitroactivityagainstawiderangeofGrampositiveandGramnegativeaerobicmicroorganisms,whichareassociatedwithuncomplicatedurinarytractinfection［1］.ThefactthatfosfomycinhasnoUVVisabsorptionhasledtothedevelopmentoffewanalyticalmethodsforitsdetermination.Asfarasweknow,onlytheH

3、PLCwithrefractiveindex(RI)detectionmethod,theBritishPharmacopoeia(BP)methodusedfor11/11analysisoffosfomycintrometamol［2a］canprovideseparationforfosfomycinandrelatedsubstances.DuetothepoorsensitivityofRIdetector,verylargeamountofsampleisinjectedwhichcausesthefosfomycinpeaktobebroadened,a

4、ndtheresolutionbetweenfosfomycinandrelatedsubstancesmightbereduced.Furthermore,duetothepoorbuffercapacityofthemobilephaseandleaststabilityoftheNH2column,theBPmethodisnotrobustenough.AccordingtoBP［2b］,fosfomycinsodiumanddisodium1,2(dihydroxypropyl)phosphonate(diolsubstance)aredetermined

5、bytitrimetricmethodwhichlacksofaccuracy.UtilizingtheChinesePharmacopoeia(ChP)method［3a］,fosfomycininfosfomycinsodiumisdeterminedbymicrobiologicalanalysis,whilefosfomycinsodiumdiolsubstancesaredeterminedbytitrimetricmethod.ThisarticleprovidedanionpairHPLCELSDmethodforthedeterminationof

6、fosfomycinandrelatedsubstancesinfosfomycinsodium.　　1ExperimentMaterials11/11FosfomycinsodiumandfosfomycincalciumwereprovidedbyShanghaiAsiaPioneerPharmaceuticalsCo.,Ltd.FosfomycinChineseNationalChemicalReferenceStandard(CRS)ofactivity651μg/mg,fosfomycintrometamolEuropeanPharmacopoeiaCR

7、Sofactivity%,andfosfomycintrometamolimpurityA(diolsubstance)EuropeanPharmacopoeiaCRSwereused.OctylaminewaspurchasedfromAldrich.AcetontrilewasHPLCgradeandobtainedfromE.Merck.Allotherchemicalswereanalyticalgradereagents.AllsolutionswerepreparedwithdistilledwaterforHPLC.Instrumen