A method for determination of polymer content in cefditoren pivoxil tablets by TSK gel chromatography was established. Experimental conditions: using a TSK gel G2000HHR column(300 mm×7.8 mm, 5 μm), the mobile phase is 30 mmol/L solution of lithium bromide in N, N-dimethylformamide for liquid chromatography at the flow rate of 0.3 mL/min, the detection wavelength is 280 nm, the column temperature is 25℃. The results show that the linear range of cefditoren pivoxil is in the range from 0.02 to 148.03 μg/mL, linear equation is y(area of peak) = 85 812x(concentration) -18 862, r=0.999 6. The detection limit is 0.01 μg/mL, the quantification limit is 0.03 μg/mL. The method is sensitive, accurate and specific, is suitable for detecting the polymers in cefditoren pivoxil tablets.
李 敏,贾玉捷,杨宏硕,马亚松,胡利敏. TSK凝胶色谱法测定头孢妥仑匹酯片中的聚合物[J]. 煤炭与化工, 2020, 43(6): 147-149,154.
Li min, Jia Yujie, Yang Hongshuo, Ma Yasong, Hu Limin. Determination of the polymers of cefditoren pivoxil tablets by TSK-gel chromatography G2000HHR. CCI, 2020, 43(6): 147-149,154.