目的 建立凝膠色譜法測定注射用頭孢美唑鈉中聚合物。方法 色譜柱為玻璃柱（內(nèi)徑1.3 cm，柱長40 cm），葡聚糖凝膠G-10（40～120 μm）為填充劑；流動相A為pH 7.0的0.1 mol/L磷酸緩沖液，流動相B為水；體積流量為1.5 mL/min；檢測波長為254 nm；藍色葡聚糖2000溶液的質(zhì)量濃度為0.1 mg/mL；進樣量200 μL。結(jié)果 A相中頭孢美唑鈉進樣質(zhì)量濃度在10～40 mg/L與頭孢美唑鈉高分子聚合物峰面積呈良好的線性關(guān)系（r=0.998 6）。B相中頭孢美唑酸進樣質(zhì)量濃度在3.994～79.88 μg/mL線性關(guān)系良好（r=0.999 9）。3批樣品中高分子聚合物質(zhì)量分數(shù)為0.02%～0.03%。結(jié)論 該方法的精密度和準確度均能滿足注射用頭孢美唑鈉中高分子聚合物質(zhì)量控制的要求。

Objective To establish a Sephadex chromatographic method for the determination of polymers in Cefmetazole Sodium for injection. Methods The analytical column (1.3 cm × 40 cm, 40—120 μm) takes Sephadex G-10 as filler; The mobile phase A was 0.1 mol/L phosphate buffer (pH 7.0) and mobile phase B was pure water; The flow rate was 1.5 mL/min; The detection wavelength was 254 nm, and the injection volumn was 200 μL. Results The calibration curve of polymers was linear in the concentration range of 10—40 mg/L (r = 0.998 6), and another calibration curve was linear in the concentration range of 3.994—79.88 μg/mL (r = 0.999 9). The content of polymer in Cefmetazole Sodium for injection was 0.02%—0.03%. Conclusion The method with satisfied accuracy and precision is suitable for the quality control of polymers in Cefmetazole Sodium for injection.