葡聚糖凝胶色谱法测定注射用头孢美唑钠中聚合物 - 天津中草药杂志社.pdf

现代药物与临床 Drugs Clinic 第 28 卷 第 2 期 2013 年 3 月 • 185 • 葡聚糖凝胶色谱法测定注射用头孢美唑钠中聚合物 1 1 2 1 刘 欢 ，郭 红 ，王 悦 ，王成港 1. 天津药物研究院 天津市药物制剂工程技术研究中心，天津 300193 2. 天津药物研究院药业有限责任公司，天津 300193 摘 要：目的 建立凝胶色谱法测定注射用头孢美唑钠中聚合物。方法 色谱柱为玻璃柱（内径 1.3 cm，柱长40 cm ），葡 聚糖凝胶 G-10（40～120 μm ）为填充剂；流动相 A 为 pH 7.0 的0.1 mol/L 磷酸缓冲液，流动相 B 为水；体积流量为 1.5 mL/min； 检测波长为 254 nm ；蓝色葡聚糖2000 溶液的质量浓度为 0.1 mg/mL ；进样量200 μL 。结果 A 相中头孢美唑钠进样质量浓 度在 10～40 mg/L 与头孢美唑钠高分子聚合物峰面积呈良好的线性关系（r=0.998 6 ）。B 相中头孢美唑酸进样质量浓度在 3.994～79.88 μg/mL 线性关系良好（r=0.999 9 ）。3 批样品中高分子聚合物质量分数为 0.02%～0.03% 。结论 该方法的精密 度和准确度均能满足注射用头孢美唑钠中高分子聚合物质量控制的要求。 关键词：注射用头孢美唑钠；高分子聚合物；Sephadex G-10 凝胶；葡聚糖凝胶色谱 中图分类号：R927.2 文献标志码：A 文章编号：1674 - 5515(2013)02 - 0185 - 03 DOI: 10.7501/j.issn.1674-5515.2013.02.020 Determination of polymers in Cefmetazole Sodium for injection by Sephadex chromatography 1 1 2 1 LIU Huan , GUO Hong , WANG Yue , WANG Cheng-gang 1. Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China 2. TIPR Pharmaceutical Responsible Co., Ltd, Tianjin 300193, China Abstract: 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 accura