高效液相色谱法测定头孢拉定制剂方法的改进

目的:改进头孢拉定制剂含量测定方法。方法:高效液相色谱条件:以Shim—Pack CLC—ODS(250mm×4.6mm)为色谱柱;柱温为35℃;流动相为水—甲醇—3.86％醋酸钠溶液-4％醋酸溶液(1364:500:30:6);流速为0.8mL·min~(-1);检测波长为254nm。结果:头孢拉定峰形良好,分离度和柱效满足药典要求,保留时间由原来的21.32min缩短至8.06min,提高了分析速度,含量测定结果与中国药典无显著差异。结论:该方法快速、准确、能更好地适用于常规检验工作和大批量生产时的质量控制。

The improved HPLC method for the determination of cefradine preparation

Objective: AIM To improve the determination method of cefradine preparation. Methods: HPLC analysis was carried out with mobile phase water-methanol—3.86％ sodium acetate solution—4％ acetic acid solution (1364: 600: 30: 6) and flow rate 0.8mL·min~(-1)on Shim-Pack CLC-ODS column (250mm×4.6mm) at temperature 35℃. Detected wavelength was 254nm. Results: Cefradine peak was in normal shape, resolution and column efficiency can meet the demands of Chinese Pharmacopoeia, retention time was shortened from 21.32min to 8.06min, and the results had no obvious differences with that of Chinese Pharmacopoeia method. Conclusion: The method was rapid, accurate and adapted to routine analysis and quality control in factory better.