【必威体育精装版word论文】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【临床医学专业论文】.doc

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【必威体育精装版word论文】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【临床医学专业论文】.doc

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【必威体育精装版word论文】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【临床医学专业论文】

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 Fosfomycin is a synthetic, broadspectrum bactericidal antibiotic for oral administration. It has in vitro activity against a wide range of Grampositive and Gramnegative aerobic microorganisms, which are associated with uncomplicated urinary tract infection［1］. The fact that fosfomycin has no UVVis absorption has led to the development of few analytical methods for its determination. As far as we know, only the HPLC with refractive index (RI) detection method, i.e. the British Pharmacopoeia (BP) method used for analysis of fosfomycin trometamol［2a］ can provide separation for fosfomycin and related substances. Due to the poor sensitivity of RI detector, very large amount of sample is injected which causes the fosfomycin peak to be broadened, and the resolution between fosfomycin and related substances might be reduced. Furthermore, due to the poor buffer capacity of the mobile phase and least stability of the NH2 column, the BP method is not robust enough. According to BP［2b］, fosfomycin sodium and disodium 1,2(dihydroxypropyl) phosphonate (diol substance) are determined by titrimetric method which lacks of accuracy. Utilizing the Chinese Pharmacopoeia (ChP) method［3a］, fosfomycin in fosfomycin sodium is determined by microbiological analysis, while fosfomycin sodium diol substances are determined by titrimetric method. This article provided an ionpair HPLCELSD method for the determination of fosfomycin and related substances in fosfomycin sodium. 1 Experiment 1.1 Materials Fosfomycin sodium and fosfomycin calcium were provided by Shanghai Asia Pioneer Pharmaceuticals Co., Ltd. FosfomycinChinese National Chemical Reference Standard (CRS) of activity 651μg/mg, fosfomycin trometamolEuropean Pharmaco