【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Spberiserb ODS(Φ3.9mm×200mm,5μm)；流动相为乙腈-0.068mol/L KH2PO4(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Hypersil C18(Φ4.6mm×200mm，5μm)；流动相为乙腈-0.068mol/L KH2PO4(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

    To detect human blood concentration of amoxicillin and sulbactam with HPLC

    GUO Li-bin，SUN Hua,QU Fu-jun. Midiciment Branch,The People’s Hospital of Longjiang County,Heilongjiang 161100,China

    【Abstract】 Objective To set up the detection method of human blood concentration of amoxicillin and sulbactam. Methods The chromatographic column was Spberiserb ODS(φ3.9mm×200mm.5μm ),and the mobile phase was acetonitrile- 0.068mol/L KH2PO4(4.5:95.5),the flow rate was 0.8ml/min,the detection wavelength was 225nm,and the column temperature was 25±0.1 ℃.We detected the human blood concentration of amoxicillin,the chromatographic colum was Hypersil C18(φ4.6mm×200mm 5μm),the mobile phase was acetonitrile-0.068mol/L KH2po4(4.5:95.5),the flow rate was 1.2ml/min,the detection wavelength was 210nm, and the column temperature was 25±0.1 ℃.We detected the human blood concentration of sulbactam. Results We found that amoxicillin and sulbactam were under the condition of selected chromatographic separation, the resolution of amoxicillin and sulblactam and the impurity in the blood plasma was favorable.The resolution was <1.5,the human blood concentration of amoxicillin was 0.125～10μg/ml, and the linear regrossion was favorable,r=0.9998.The human blood concentration of sulbactam was 0.10～10μg/ml,and the linear regrossion was favorable,r=0.9999.The average recovery of amoxicillin and sulbactam were 96.25%and 102.3%.The two kinds of components were RSD<10%in a day or next.Conclusion The study shows that we can detect the human blood concentration of amoxicillin and sulbactam with HPLC,and the method has very good accuracy,precision and sensitivity.It is accord with demands of drug detection. ......