RP-HPLC测定氨苄西林丙磺舒胶囊中的有关物质

Determination of Related Substance in Ampicillin and Probenecid Capsules by RP-HPLC

目的建立氨苄西林丙磺舒胶囊有关物质的RP-HPLC梯度洗脱方法。方法色谱柱为十八烷基硅烷键合硅胶柱;流动相A为2 mol/L醋酸溶液-0.2 moL/L磷酸二氢钾溶液-乙腈-水(0.5:50:50:900);流动相B为2 moL/L醋酸溶液-0.2 mol/ L磷酸二氢钾溶液-乙腈-水(0.5:50:400:550),流速为1 ml/min,线性梯度洗脱;检测波长为254 nm,柱温40℃,进样器15℃,进样量为20μl。结果该方法能专属、准确地测定氨苄西林丙磺舒胶囊中的有关物质。结论本色谱条件适合氨苄西林丙磺舒胶囊有关物质的测定,可纳入氨苄西林丙磺舒胶囊质量标准。

Objective To establish a HPLC method to analyze the quality of ampicillin and probenecid capsules. Methods C18 column with temperature at 40℃ was used, the mobile phase of gradient elution was composed of solution A （2 mol/L HAc -0.2 mol/L K H2PO4-ACN-H2O（0.5： 50： 50： 900） and solution B （2 mol/L HAc -0.2 mol/L KH2PO4-ACN-H2O（0.5： 50： 400： 550） ） ,the elution was performed at the flow rate of 1 ml/min. UV detective wavelength was 254 nm, the temperature of injection machine was 15 ℃ ,injection volume was 20μl. Results The related substance in ampicillin and probenecid capsules could be detected exactly and exclusively. Conclusion This method is suitable for determination of related substance in ampicillin and probenecid capsules. It can be adopted to the quality control of ampicillin and probenecid capsules.