凝胶色谱法测定头孢克肟缓释微丸胶囊中高分子聚合物  

Determination of polymer in cefixime sustained release pellet capsules by gel filtration chromatography

作　　者：李俊霞 相莉[2] 陈少华[2] 张宇佳 郑稳生[2] 

机构地区：[1]天津药业集团新郑股份有限公司,河南新郑246052 [2]中国医学科学院北京协和医学院药物研究所,北京100050

出　　处：《中南药学》2014年第12期1228-1230,共3页Central South Pharmacy

摘　　要：目的建立凝胶色谱法测定头孢克肟缓释微丸胶囊中的高分子聚合物。方法选用Sephadex G-10柱（400 mm×13 mm,40-120μm）色谱柱,流动相A为p H=7.0的0.01 mol·L^-1磷酸盐缓冲液,流动相B为水,流速为1.0 mL·min^-1,检测波长为254 nm,进样量为20μL。结果头孢克肟缓释微丸胶囊中高分子聚合物在0.515-2.013 mg·mL^-1与峰面积呈良好的线性关系（r=0.999 7）,头孢克肟缓释微丸胶囊中高分子聚合物含量〈0.1%。结论该方法简便、准确、灵敏度高,适用于头孢克肟缓释微丸胶囊中高分子聚合物的控制。Objective To establish a gel filtration chromatography method for the determination of polymer in cefixime sustained release pellet capsules. Methods The chromatographic column was Sephadex G-10（400 mm×13 mm, 40- 120 μm）, the mobile phase A was 0.01 mol·L^- 1 phosphate buffer（pH = 7.0） and the mobile phase B was water. The flow rate was 1.0 m L·min^- 1, the detection wavelength was 254 nm and the injection volume was 20 μL. Results A good linearity was obtained between the peak area and concentration at 0.515- 2.013 mg·mL^-1（r= 0.999 7）. The content of polymer in cefixime sustained release pellet capsules was less than 0.1%. Conclusion The method is simple, accurate and sensitive for the control of polymer in cefixime sustained release pellet capsules.

关 键 词：头孢克肟 缓释微丸 胶囊 高分子聚合物 凝胶色谱法 

分 类 号：R917[医药卫生—药物分析学]