【摘要】 目的建立高效液相色谱法测定头孢拉定胶囊中的有关物质。方法采用高效液相色谱法。色谱柱为十八烷基硅烷键合硅胶色谱柱（150 mm×4.6 mm,5μm）,流动相A为2.72g·L^-1磷酸二氢钾（用稀磷酸调节pH值至3.0）,流动相B为甲醇,进行梯度洗脱;紫外检测波长为220 nm;柱温为30℃;流速为1.0 mL·min^-1。结果头孢拉定胶囊中各杂质峰均分离完全,在相应范围内与峰面积线性关系良好,平均回收率均在93%～108%。结论本方法操作简便,准确度高,适用于头孢拉定胶囊的有关物质测定。更多还原

【Abstract】 Objective To establish a method for the determination of related substances in cefradine capsules by HPLC.Methods HPLC was performed on a C₁₈ column （150 mm×4.6 mm,5μm）,with the mobile phase A of 2.72 g·L^-1 potassium dihydrogen phosphate buffer （adjusting pH to 3.0with phosphoric acid）,and mobile phase B of methanol for the linear gradient elution.The detection wavelength was 220 nm.The column temperature was 30℃,and the flow rate was 1.0 mL·min^-1.Results Each impurity peak in cefradine capsules was completely separated.The calibration curves were linear in their corresponding ranges,and the recoveries of these impurities were between93%-108%.Conclusion This simple,accurate method can be used for the determination of related substances in cefradine capsules.更多还原