葡聚糖凝胶色谱法测定注射用头孢美唑钠中聚合物

Determination of polymers in Cefmetazole Sodium for injection by Sephadex chromatography

目的建立凝胶色谱法测定注射用头孢美唑钠中聚合物。方法色谱柱为玻璃柱(内径1.3cm,柱长40cm),葡聚糖凝胶G-10(40～120μm)为填充剂;流动相A为pH7.0的0.1mol/L磷酸缓冲液,流动相B为水;体积流量为1.5mL/min;检测波长为254nm;蓝色葡聚糖2000溶液的质量浓度为0.1mg/mL;进样量200μL。结果 A相中头孢美唑钠进样质量浓度在10～40mg/L与头孢美唑钠高分子聚合物峰面积呈良好的线性关系(r=0.9986)。B相中头孢美唑酸进样质量浓度在3.994～79.88μg/mL线性关系良好(r=0.9999)。3批样品中高分子聚合物质量分数为0.02%～0.03%。结论该方法的精密度和准确度均能满足注射用头孢美唑钠中高分子聚合物质量控制的要求。

Objective To establish a Sephadex chromatographic method for the determination of polymers in Cefmetazole Sodium for injection.Methods The analytical column（1.3 cm × 40 cm,40—120 μm） takes Sephadex G-10 as filler;The mobile phase A was 0.1 mol/L phosphate buffer（pH 7.0） and mobile phase B was pure water;The flow rate was 1.5 mL/min;The detection wavelength was 254 nm,and the injection volumn was 200 μL.Results The calibration curve of polymers was linear in the concentration range of 10—40 mg/L（r = 0.998 6）,and another calibration curve was linear in the concentration range of 3.994—79.88 μg/mL（r = 0.999 9）.The content of polymer in Cefmetazole Sodium for injection was 0.02%—0.03%.Conclusion The method with satisfied accuracy and precision is suitable for the quality control of polymers in Cefmetazole Sodium for injection.