目的 建立葡聚糖凝胶色谱法测定盐酸头孢替安的聚合物。方法 色谱柱为葡聚糖凝胶Sephadex G10柱（400 mm×10 mm）；流动相A为0.01 mol/L磷酸盐缓冲液（pH 7.0），流动相B为水；检测波长254 nm，进样量200 μL，体积流量1.5 mL/min。结果 盐酸头孢替安样品溶液的质量浓度在11.99～40.01 mg/mL与聚合物峰面积之间的线性关系良好（r=0.999 5），盐酸头孢替安中聚合物质量分数小于0.5%。结论 该方法简便、准确、灵敏度高，适用于盐酸头孢替安聚合物的控制。

Objective To establish a method of Sephadex gel chromatography for the determination of polymer in cefotiam hydrochloride. Methods The analysis was performed on Sephadex G10 column (400 mm×10 mm), 0.01 mol/L phosphate buffer (pH 7.0) served as mobile phase A, and pure water as mobile phase B. The detection wavelength was 254 nm with the injection volume of 200 μL at a flow rate of 1.5 mL/min. Results The calibration curves were linear in the range of 11.99 — 40.01 mg/mL between concentration and peak area (r=0.9995), and and the content of polymer in cefotiam hydrochloride was below 0.5%. Conclusion The method is simple, accurate, sensitive, and reproducible, and could be used to determine polymer in cefotiam hydrochloride.

国家重点基础研究发展计划（973计划）项目（2012CB724000，2012CB724002）