注射用头孢美唑钠高分子聚合物检查方法的建立与验证

Development and validation for determination of high molecular polymers concentration in cefmetazole sodium for injection

目的：建立注射用头孢美唑钠中高分子聚合物分离分析的质量控制方法。方法：采用分子排阻色谱法，色谱柱为Sephadex G-10（300mm×10mm，40—120μm），流动相A为0．075mol／L磷酸盐缓冲液（pH7．0），流动相B为水；流速为1．5ml／min，检测波长为280nm，进样量为100μl，采用自身对照外标法定量。结果：在2．897～144．9μg／ml范围内样品浓度与聚合物峰面积呈良好线性关系（r=1．0000），检出限29ng。结论：该方法快速、简便、准确、重复性好，适用于注射头孢美唑钠中高分子聚合物的分析。

Objective： To development and validate the method of separating and determining the highmolecular polymers in eefmetazole sodium for injection for quality control. Methods： Gel filtration chromatography was performed by using Sephadex G10 gel column. The mobile phase was consisted of A, 0. 075mol/L phosphate buffer （ pH 7.0） and B water. The flow rate was 1.5 ml/min, the detection wavelength was 280 nm and the injection volume was 100 μl. The concentration of polymers was quantified by external standard method of cefmetazol. Results： The linearity of the polymers in Cefmetazol was 2. 897 - 144.9 μg/ml （r = 1. 000 0） , the detection limit was 29 ng. Conclusions ： This method was simple and accurate for the determination of the polymers in cefmetazole .