目的:建立高效液相色谱法测定注射用头孢拉定聚合物的含量。方法:采用高效液相色谱法,色谱柱为TSK-GEL G2000SWXL凝胶色谱柱,流动相为pH 8.0的0.2 mol/L磷酸盐缓冲液即0.2 mol/L磷酸氢二钠溶液-0.2 mol/L磷酸二氢钠溶液(95∶5),检测波长210 nm,柱温30℃,流速1 mL/min,进样量20μL。结果:头孢拉定对照品检测线性范围为5.21~208.57μg/mL(r=0.99997),注射用头孢拉定聚合物检测线性范围为0.17~3.37 mg/mL(r=0.999),聚合物定量限为0.14μg。结论:该方法测定注射用头孢拉定聚合物专属性好,快速,分离度好,可用于注射用头孢拉定聚合物的检测。 Objective: To establish a method for the determination of cephradine polymer for injection by high performance liquid chromatography. Methods: The chromatographic column was TSK-GEL G2000SWXL and the mobile phase consisted of 0.2 mol / L phosphate buffer solution (pH 8.0), 0.2 mol / L sodium hydrogen phosphate solution (0.2 mol / L) Sodium dihydrogen phosphate solution (95: 5), detection wavelength 210 nm, column temperature 30 ℃, flow rate 1 mL / min, injection volume 20μL. Results: The linear range of cefradine reference substance was 5.21 ~ 208.57μg / mL (r = 0.99997). The linear range of cefradine injection was 0.17 ~ 3.37 mg / mL (r = 0.999) and the limit of quantification was 0.14μg. Conclusion: The method for the determination of cefradine for injection of polymer specificity, fast, good resolution, can be used for injection of cephradine polymer detection.