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目的建立注射用头孢噻吩钠高分子聚合物含量的测定方法。方法采用凝胶色谱法,Sephadex G10色谱柱;流动相A为0.025mol·L-1磷酸盐缓冲液(pH7);流动相B为水;流速1.5ml·min-1;检测波长为254nm,进样量为200μl,自身对照外标法定量。结果注射用头孢噻吩钠进样浓度在5～50mg·ml-1范围内与其聚合物的峰面积呈良好的线性关系(r=0.9992),头孢噻吩对照品进样浓度在20～204ug·ml-1与其缔合峰的峰面积也呈良好的线性关系(r=0.9998)。结论本法测定注射用头孢噻吩钠的聚合物含量准确、重现性好。
Objective To establish a method for the determination of cefalotime sodium polymer for injection. Methods The mobile phase A was 0.025 mol·L-1 phosphate buffer (pH7). The mobile phase B was water. The flow rate was 1.5 ml · min-1. The detection wavelength was 254 nm. Sample volume of 200μl, its own control external standard method. Results The injection of cefalothion sodium injection concentration in the range of 5 ~ 50mg · ml-1 and its polymer peak area showed a good linear relationship (r = 0.9992), the injection of cefalothin reference substance concentration 20 ~ 204ug · ml- 1 and its associated peak area also showed a good linear relationship (r = 0.9998). Conclusion The method for the determination of cefalotin sodium for injection is accurate and reproducible.