论文部分内容阅读
目的建立注射用哌拉西林钠高分子聚合物含量的测定方法。方法采用凝胶色谱法,色谱柱为Sephadex G10色谱柱;流动相A为0.025mol·L-1磷酸盐缓冲液(pH7.0);流动相B为水;流速1.0ml·min-1;检测波长为254nm,进样量为200μl,自身对照外标法定量。结果注射用哌拉西林钠进样浓度在5～60mg·ml-1范围内与其聚合物的峰面积呈良好的线性关系(r=0.9996),哌拉西林钠对照品进样浓度在18～110μg·ml-1与其缔合峰的峰面积也呈良好的线性关系(r=0.9993)。结论本法测定注射用哌拉西林钠的聚合物含量准确、重现性好。
Objective To establish a method for the determination of the content of piperacillin sodium polymer for injection. Methods The column was Sephadex G10. The mobile phase A was 0.025 mol·L-1 phosphate buffer (pH7.0). The mobile phase B was water. The flow rate was 1.0 ml · min-1. Wavelength of 254nm, injection volume of 200μl, its own control external standard method. Results The concentration of piperacillin sodium for injection was linearly proportional to the peak area of polymer in the range of 5 ~ 60 mg · ml-1 (r = 0.9996), the concentration of piperacillin sodium reference substance was in the range of 18 ~ 110 μg There was also a good linear relationship between the peak area of ml-1 and its associated peaks (r = 0.9993). Conclusion The method for the determination of piperacillin sodium for injection has good polymer content and good reproducibility.