目的 建立葡聚糖凝膠色譜法測定鹽酸頭孢替安的聚合物。方法 色譜柱為葡聚糖凝膠Sephadex G10柱（400 mm×10 mm）；流動相A為0.01 mol/L磷酸鹽緩沖液（pH 7.0），流動相B為水；檢測波長254 nm，進樣量200 μL，體積流量1.5 mL/min。結果 鹽酸頭孢替安樣品溶液的質(zhì)量濃度在11.99～40.01 mg/mL與聚合物峰面積之間的線性關系良好（r=0.999 5），鹽酸頭孢替安中聚合物質(zhì)量分數(shù)小于0.5%。結論 該方法簡便、準確、靈敏度高，適用于鹽酸頭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.

國家重點基礎研究發(fā)展計劃（973計劃）項目（2012CB724000，2012CB724002）