摘要
目的采用TSK凝胶色谱柱对头孢妥仑匹酯中的高分子聚合物进行测定。方法高效液相色谱法,以TSK-gel G2000 SW_(XL)(7.8 mm×300 mm)为色谱柱,流动相为水-甲醇(5∶95,V/V),流速为0.7 ml/min,检测波长为230 nm,进样体积为20μl。结果高分子聚合物峰与主成分头孢妥仑匹酯峰能够有效分离,头孢妥仑匹酯主成分的线性范围为5.35μg/ml^1 694.00μg/ml(r=0.998 5),在该范围内,供试品溶液浓度与聚合物峰面积呈良好线性关系(r=0.999 6);定量限为0.54μg/ml,检测限为0.16μg/ml;方法的精密度良好(RSD=0.21%);样品测定的重复性较好(RSD=0.62%)。结论该方法简便,快速,灵敏度高,重复性好,可用于头孢妥仑匹酯及其他脂溶性抗生素中高分子聚合物的检测。
Objective To establish a method for the determination of high molecular polymers in Cefditoren Pivoxil by TSK - gel G2000SWXL column. Methods The Chromatographic column was TSK -gel G2000 SWxL （7. 8 mm × 300 ram） ; the mo- bile phase was water- methanol（5 ： 95, V/V） ; the flow rate was 0.7 ml/min; the detection wavelength was 230 nm and the injection volume was 20 μl. Results The high molecular polymers were separated completely from Cefditoren Pivoxil. The con- centration of solution was in good linear relationship with the peak area of polymer when the concentration of Cefuroxime Axetil was within 5.35 μg/ml - 1 694.00 μg/ml （r = 0. 998 5 ）. The limit of detection was 0.16 μg/ml, and the limit of quantifica- tion was 0.54 μg/ml. The RSD for replicate injections of reference solution was 0.21% , the repetitiveness was fine with the RSD of 0.62%. Conclusion The method is simple, rapid, sensitive and repeatable. It＇s suitable for the determination of the high molecular polymers in Cefditoren Pivoxil and other liposolubile antibiotics.
出处
《中国卫生检验杂志》
CAS
2017年第12期1700-1702,共3页
Chinese Journal of Health Laboratory Technology
关键词
头孢妥仑匹酯
聚合物
TSK
Cefditoren Pivoxil
High molecular polymers
TSK
