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1、HPLC法测定阿莫西林舒巴坦酯片人体血药浓度【摘要】目的建立阿莫西林舒巴坦酯片中阿莫西林和舒巴坦的血药浓度测定方法。方法以色谱柱为SpberiserbODS(Φ3.9mm×200mm,5μm)；流动相为乙腈-0.068mol/LKH2PO4(4.5：95.5)；流速为0.8ml/min;检测浓度为225nm;柱温为（25±0.1）℃方法测定人体内阿莫西林血药浓度。以色谱柱为HypersilC18(Φ4.6mm×200mm，5μm)；流动相为乙腈-0.068mol/LKH2PO4(4.5：95.5);流速为1.2ml/min;检测波长为210nm;柱温为（25±0.1）℃方法测定人体
2、内舒巴坦血药浓度。结果阿莫西林和舒巴坦在选定的色谱分离条件下，与血浆中杂质峰分离良好，分离度大于1.5。阿莫西林血浆药物浓度在0.125～10μg/ml范围内线性良好，r=0.9998;舒巴坦血浆药物浓度在0.10～10μg/ml范围内线性良好，r=0.9999。阿莫西林和舒巴坦的平均回收率分别为96.25%、102.3%。两种成分的日内、日间RSD＜10%。结论HPLC法测定方人体内阿莫西林和舒巴坦血药浓度方法准确度精度和灵敏度均较高，符合血浆中药物测定要求。【关键词】阿莫西林舒巴坦酯片；高效液相色谱法；血药浓度Todetecthumanbloodconcentrationofa
3、moxicillinandsulbactamwithHPLC【Abstract】ObjectiveTosetupthedetectionmethodofhumanbloodconcentrationofamoxicillinandsulbactam.MethodsThechromatographiccolumnwasSpberiserbODS(φ3.9mm×200mm.5μm),andthemobilephasewasacetonitrile-0.068mol/LKH2PO4(4.5:95.5),theflowratewas0.8ml/min,thedetectionwavelen
4、gthwas225nm,andthecolumntemperaturewas25±0.1℃.Wedetectedthehumanbloodconcentrationofamoxicillin,thechromatographiccolumwasHypersilC18(φ4.6mm×200mm5μm),themobilephasewasacetonitrile-0.068mol/LKH2po4(4.5:95.5),theflowratewas1.2ml/min,thedetectionwavelengthwas210nm,andthecolumntemperaturewas25±0.
5、1℃.Wedetectedthehumanbloodconcentrationofsulbactam.ResultsWefoundthatamoxicillinandsulbactamwereundertheconditionofselectedchromatographicseparation,theresolutionofamoxicillinandsulblactamandtheimpurityinthebloodplasmawasfavorable.Theresolutionwas<1.5,thehumanbloodconcentrationofamoxicillin
6、was0.125～10μ7g/ml,andthelinearregrossionwasfavorable,r=0.9998.Thehumanbloodconcentrationofsulbactamwas0.10～10μg/ml,andthelinearregrossionwasfavorable,r=0.9999.Theaveragerecoveryofamoxicillinandsulbactamwere96.25%and102.3%.ThetwokindsofcomponentswereRSD<10%inadayornext.ConclusionThestudyshow
7、sthatwecandetectthehumanbloodconcentrationofamoxicillinandsulbactamwithHPLC,andthemethodhasverygoodaccuracy,precisionandsensitivity.Itisaccordwithdemandsofdrugdetection.【Keywords】amoxicillinandsulbactam;liquidchromatography;bloodconcent
