摘要
目的建立用分子排阻色谱法分析头孢氨苄聚合物的方法。方法色谱柱:Sephadex G-10色谱柱(15.0mm×300mm,40～120μm);流动相A:pH8.0的0.2mo1/L磷酸盐缓冲液[0.2mo1/L磷酸氢二钠溶液-0.2mo1/L磷酸二氢钠溶液(95:5)];流动相B:超纯水;检测波长:254nm;流速:1.5mL/min。以头孢拉定作对照加校正因子外标法定量(头孢氨苄:头孢拉定=1:1)。结果头孢氨苄聚合物在1～20μg/mL范围内呈良好的线形关系(r=0.9992)。结论方法简便易行,能较好的分离头孢氨苄与其聚合物,且精密度、准确度均能满足质量控制的要求。
Objective To establish a method for the determination of polymer in cefalexin by molecular- exclusion chromatographic. Methods The analytical column was Sephadex G-10（15.0mm×300mm, 40-120μm）; the mobile phase A was 0.2 mol/L phosphate buffer（pH8.0）; the mobile phase B was water; the detection wavelength was set at 254nm; the flow rate was 1.5 mL/min. The concentration of polymers was quantified by external standard method of cefradine with a correct factor （cefalexin：cefradine=l：l） . Results The calibration cure of the polymers was linear within concentration range of l-20μg/mL （r=0.9992） . Conclusion The method was convenient and accurate. The method is promising for the separation of polymers, and the accuracy and precision are suitable for the drug quality contol.
出处
《国外医药（抗生素分册）》
CAS
2012年第2期83-86,共4页
World Notes on Antibiotics
关键词
分子排阻色谱法
头孢氨苄
聚合物
molecular-exclusion chromatographic
cefalexin
polymer
