摘要
目的建立测定头孢丙烯分散片中高分子杂质的方法。方法采用凝胶色谱法，色谱填料为葡聚糖凝胶G-10，流动SRA为pH7．0的0．05mol／L磷酸盐缓冲液，流动相B为0．001mol／L氢氧化钠溶液，流速为每分钟1．0mL，检测波长为254nm。结果头孢丙烯对照溶液在0．99-79．15ug／mL浓度范围内，峰面积与浓度呈良好的线性关系，回归方程为y=204．34x＋97．68（r=1．oooo），检测限为0．11txg／mL，日内和目问精密度的RSD％分别为3．6％和4．3％，头孢丙烯分散片中高分子杂质的含量均小于0．02％。结论本法简便、灵敏、重复性好，适于头孢丙烯分散片中高分子杂质的测定。
Objective To establish a gel filtration chromatography method for determination of the polymer in cefprozil dispersible tablets. Methods Using a gel filtration chromatography, The chromatographic column was Sephadex G-10 （15.0mmx300mm）; mobile phase A, 0.05moFL phosphate bufer（pHT.0）; mobile phase B, 0.001moFL sodium hydroxide solution; the flow rate was 1.0mL/min; the detection wavelength was 254nm. Results The good linearity was obtained between peak area and concentration ranging from 0.99-79.15gg/mL, The content of polymer in cefprozil dispersible tablets is less than 0.02%. Conclusion The method is simple, accurate and sensitive for the control of the polymer in cefprozil dispersible tablets.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2013年第5期348-350,I0007,共4页
Chinese Journal of Antibiotics
关键词
头孢丙烯
分散片
高分子杂质
凝胶色谱
Cef-prozil
Dispersible tablets
Polymer
Gel filtration chromatozraohv
作者简介
王光强，男，生于1960年，本科，主要从事药物研发工作。通讯作者，E-mail：chen_jed@126．com。
