摘要
目的采用反相高效液相色谱法测定注射用氨苄西林钠有关物质,并对有关物质进行分析。方法采用Ultimate TM XB C18(5μm,4.6mm×250mm)色谱柱,流动相A为12%醋酸溶液-0.2mol/L磷酸二氢钾溶液-乙腈-水(0.5:50:50:900);流动相B为12%醋酸溶液-0.2mol/L磷酸二氢钾溶液-乙腈-水(0.5:50:400:550);柱温:35℃;流速:1.0ml/min;检测波长:254nm。结果氨苄西林与有关物质可完全分离,L-氨苄西林、氨苄西林开环二聚物、氨苄西林闭环二聚物分别在相对主峰保留时间为0.7、2.8、3.5倍处出峰。结论定位注射用氨苄西林钠三种杂质峰位。
Objective To use an RP-HPLC method for determination of related substances in ampicillin sodium for injection,and analyse the impurity types of ampicillin sodium for injection.Methods The RP-HPLC method was performed on Ultimate TM XB C18 column（5 μm,4.6 mm × 250 mm）,the mobile phase A was 12%Nacetic acid-0.02 mol/L monobasic potassium-acetonitrile-water（0.5：50：50：900）,the mobile phase B was 12%Nacetic acid-0.02 mol/L monobasic potassium-acetonitrile-water（0.5：50：400：550）,the detection wavelength was 254 nm,the column temperature was 35℃,The flow rate was 1.0 ml/min.Results The related substances in ampicillin sodium and the impurity were separated successfull.The relative retention times are about 0.7 for L-ampicillin ampicillin,2.8 for ring-opening ampicillin dimeroates and 3.5 for ring-closing ampicillin dimeroates.Conclusion The peak potential of three impurities in an HPLC chromatogram are determined.
出处
《中国现代药物应用》
2010年第12期4-5,共2页
Chinese Journal of Modern Drug Application
