目的 建立凝膠色譜法測(cè)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(zhǎng)40 cm），葡聚糖凝膠G-10（40～120 μm）為填充劑；流動(dòng)相A為pH 7.0的0.1 mol/L磷酸緩沖液，流動(dòng)相B為水；體積流量為1.5 mL/min；檢測(cè)波長(zhǎng)為254 nm；藍(lán)色葡聚糖2000溶液的質(zhì)量濃度為0.1 mg/mL；進(jìn)樣量200 μL。結(jié)果 A相中頭孢美唑鈉進(jìn)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(jìn)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?jǐn)?shù)為0.02%～0.03%。結(jié)論 該方法的精密度和準(zhǔn)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.