葡聚糖凝胶色谱法测定盐酸头孢甲肟中高分子聚合物

Determination of polymers in cefmenoxime hydrochloride by sephadex G-10 column method

目的建立葡聚糖凝胶色谱法测定盐酸头孢甲肟的聚合物的方法。方法色谱柱为葡聚糖凝胶Sephadex G-10（15 mm×35 cm）;流动相A：0.1 mol·L^-1磷酸盐缓冲液（pH7.0）,流动相B：水;流速：1.0 ml·min^-1;检测波长为254 nm,进样量为200μl。结果供试品溶液在3.10-46.20 g·L^-1浓度范围内,溶液的浓度与聚合物峰面积呈良好的线性关系（r=0.9993）;盐酸头孢甲肟对照品在0.025-0.25 g·L^-1浓度范围内,溶液的浓度与对照品峰面积呈良好的线性关系（r=0.9997）。结论本测定方法简便,灵敏性高,重复性好。

Aim To establish a method for determination of polymers in cefmenoxime hydrochloride for injection. Methods The chromatographic column was Sephadex G-10 （15 mm × 35 cm）. Mobile phase A was 0.1 mol·L^-1 phosphate buffer （pH7.0） and mobile phase B was pure water. The flow rate was 1.0 ml·min^-1. The detection wavelength was 254 nm and the injection volume was 200 μl. Result The polymers＇ calibration curve was linear in the concentration range of 3.10 -46.20 g ·L^-1 （ r = 0.9993 ） and another calibration curve was linear in the concentration range of 0. 025 - 0.25 g·L^-1 too. Conclusion The method is good at separating polymers, and its racy and precision are suitable for the drug＇ s quality control.