[关键词]
[摘要]
目的 将《中国药典》项下注射用头孢噻肟钠有关物质测定法的色谱参数进行转化,缩短液相分析时间,提高检测效率。方法 采用Waters Xselect HSS T3 C18柱(100 mm×3 mm,2.5 μm)色谱柱,流动相A为0.05 mol· L-1磷酸盐缓冲液(pH 6.25)-甲醇(86:14),流动相B为0.05 mol· L-1磷酸盐缓冲液(pH 6.25)-甲醇(60:40),先以流动相A-流动相B (95:5)等度洗脱,待头孢噻肟钠洗脱完毕后,立即进行线性梯度洗脱(0~0.7 min 95%→75% A,0.7~2.7 min 75% A,2.7~7.8 min 75%→0 A,7.8~9.5 min 100% B,9.5~11.2 min 0→95% A,11.2~14.6 min 95% A),体积流量为0.5 mL·min-1,进样体积为2 μL,检测波长为235 nm。结果 色谱参数转化后运行时间从80 min缩短至26 min,方法专属性、稳定性、色谱柱耐用性均良好。结论 色谱参数转化后的方法专属、节能环保,可用于注射用头孢噻肟钠的有关物质检测。
[Key word]
[Abstract]
Objective Transformation of chromatographic parameters in determination of related substances of Cefotaxime Sodium for Injection in chinese pharmacopoeia to shorten the analysis time and improve the efficiency. Methods Waters Xselect HSS T3 C18 (100 mm×3 mm, 2.5 μm) was adopted with 0.05 mol·L-1 phosphate buffer (pH 6.25) -methanol (86:14) as mobile phase A, 0.05 mol· L-1 phosphate buffer (pH 6.25) -methanol (60:40) as mobile phase B. The mobile phase A and B (95:5) were used for constant elution. After the elution of cefotaxime sodium, linear gradient elution was performed immediately (0-0.7 min 95%→75% A, 0.7-2.7 min 75% A, 2.7-7.8 min 75%→0 A, 7.8-9.5 min 100% B, 9.5-11.2 min 0 A→95% A, 11.2-14.6 min 95% A), the flow rate was 0.5 mL·min-1, the injection volume was 2 μL, and the detection wavelength was 235 nm. Results After the conversion of chromatographic parameters, the running time was reduced from 80 min to 26 min, and the specificity, stability and durability of chromatographic column were good. Conclusion The method after the transformation of chromatographic parameters is rapid, exclusive, energy saving and environmental protection. It can be used for the determination of related substances of Cefotaxime Sodium for Injection.
[中图分类号]
R917
[基金项目]