【摘要】 目的建立高效葡聚糖凝胶色谱法测定注射用盐酸头孢替安聚合物。方法采用葡聚糖凝胶Sephadex G-10柱(300mm×15mm);以pH7.0的0.05mol/L磷酸盐缓冲液[0.05mol/L磷酸氢二钠溶液:0.05mol/L磷酸二氢钠溶液(61:39)]为流动相A,以水为流动相B,流速为1.0mL/min,柱温为40℃,检测波长为254nm,进样量200μL,外标法定量。结果注射用盐酸头孢替安样品在10.002~58.065mg/mL浓度范围内,与聚合物峰面积呈良好的线性关系。重复性(RSD)为0.05%;样品溶液室温放置4h内不稳定,需要溶解后立即测定。12批供试品与原研样品中聚合物均远小于0.5%的规定限度。结论该方法能够较好的分离盐酸头孢替安及其聚合物,适用于注射用盐酸头孢替安中聚合物的质量控制。更多还原

【Abstract】 Objective To establish a method of high performance sephadex gel chromatography for the determination of polymer in cefotiam hydrochloride for injection.Methods The analysis was performed on Sephadex G10 column(300mm×15mm),0.05mol/L phosphate buffer(pH7.0) served as mobile phase A,and pure water as mobile phase B.The detection wavelength was 254 nm with the injection volume of 200μL at a flow rate of 1.0mL/min.The content was determined by external standard method.Results The calibration curves were linear in the range of 10.002~58.065mg/mL between concentration and peak area.The RSD of repeatability was 0.05%; Because of its instability in 4h at room temperature,the sample solution should be immediately determined after being dissolved.The contents of polymer in cefotiam hydrochloride for injection in 12 batches samples and the original research sample were below 0.5%,respectively.Conclusion The cefotiam hydrochloride and polymers were well separated by this method,which can be used to determine the content of polymer in cefotiam hydrochloride for injection.更多还原