HPLC法测定氨苄西林丙磺舒胶囊有关物质

目的建立氨苄西林丙磺舒胶囊有关物质的HPLC测定方法。方法采用Waters-C18柱(150mm×4.6mm,5μm,W03061M029),流动相A为12%醋酸溶液-0.2mol.L-1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-1磷酸二氢钾溶液-乙腈-水(0.5∶50∶400∶550),流速:1.0mL.min-1;检测波长为230nm。结果在选定条件下,有关物质与氨苄西林、丙磺舒二主药完全分离,氨苄西林在0.1~1.6mg.mL-1、丙磺舒在0.028~0.448mg.mL-1范围内线性关系良好。结论本法简便、准确,重现性好,可用于氨苄西林丙磺舒胶囊有关物质的检测。

HPLC measurement of related substances in ampicillin and Probenecid capsules

OBJECTIVE To establish a method for measurement of related substances in ampicillin and Probenecid capsules.METHODS The chromatogramphic conditions adopted were:Waters-C18 column(150mm×4.6mm,5μm,W03061M029),mobile phase A was 12% acetic acid solution-0.2mol·L-1 potassium dihydrogen phosphate-acetonitrile-water(0.5∶50∶50∶900)and mobile phase B was 12% acetic acid solution-0.2mol·L-1 potassium dihydrogen phosphate-acetonitrile-water(0.5∶50∶400∶550),flow rate was 1.0mL·min-1,and detection wavelength was 230nm.RESULTS The related substances can be completely separated from ampicillin and Probenecid,a linear range of 0.1～1.6mg·mL-1 ampicillin and 0.028～0.448mg·ml-1 probenecid.CONCLUSION A simple,accurate and specific method is established for determination of related substances in ampicillin and Probenecid capsules.