Hendrix C, Yongxin Z, Pijcke M, Roets E, Hoogmartens J
Katholieke Universiteit Leuven, Laboratorium voor Farmaceutische Chemie, Instituut voor Farmaceutische Wetenschappen, Belgium.
J Pharm Biomed Anal. 1993 Jul;11(7):595-9. doi: 10.1016/0731-7085(93)80010-x.
A comparative study of two isocratic liquid chromatographic methods for the analysis of cefradine is described. The first method is prescribed by the European Pharmacopoeia for the assay of cefradine, using classical alkyl bonded phase (C18) as the stationary phase. Poor reproducibility of the selectivity towards cefradine and its related substances was observed when this method was used and none of the C18 columns examined was able to separate cefradine completely from its potential related substances under the prescribed LC conditions. On the other hand, the second method, which uses poly(styrene-divinylbenzene) as the stationary phase, shows good selectivity even when using columns from different manufacturers and of different age. Four bulk samples of cefradine were analysed following both methods and the results were compared.
本文描述了两种用于头孢拉定分析的等度液相色谱方法的比较研究。第一种方法是欧洲药典规定的头孢拉定含量测定方法,使用经典的烷基键合相(C18)作为固定相。使用该方法时,对头孢拉定及其相关物质的选择性重现性较差,在所检查的C18色谱柱中,没有一根能够在规定的液相色谱条件下将头孢拉定与其潜在的相关物质完全分离。另一方面,第二种方法使用聚(苯乙烯 - 二乙烯基苯)作为固定相,即使使用不同制造商和不同使用年限的色谱柱,也显示出良好的选择性。按照这两种方法对四个头孢拉定原料药样品进行了分析,并对结果进行了比较。