目的 建立HPLC法检测头孢克肟分散片中有关物质。方法 采用Inertsil ODS-3色谱柱（250 mm×4.6 mm，5μm）；流动相：四丁基氢氧化铵溶液–乙腈（75：25）；检测波长：254 nm；柱温：40℃；体积流量：调整流速使头孢克肟主峰保留时间在15～20 min；进样体积：20 μL。结果 该法专属性良好，干扰性符合相关要求，头孢克肟与相邻杂质以及各已知杂质之间的分离均良好；头孢克肟和各已知杂质的质量浓度与峰面积之间线性关系均良好（r>0.999 5）；精密度、准确度和耐用性均良好；头孢克肟分散片6批自制品与3批参比制剂的杂质谱基本一致，各批样品均符合制订质量标准的规定。结论 所建立的方法可用于简便、快速、准确地检测头孢克肟分散片中有关物质。

Objective To establish a method for the determination of related substances in Cefixime Dispersible Tablets by HPLC. Methods The chromatographic separation of the related substances was performed on an Inertsil ODS-3 column (250 mm×4.6 mm, 5 μm) with tetrabutylammonium hydroxide solution- acetonitrile (75:25) as mobile phase. The detection wavelength was 254 nm. The column temperature was 40℃. Volume flow rate adjusted the flow rate so that the retention time of the main peak of cefixime was 15-20 min with injection volume of 20 μL. Results The established method had good specificity, satisfactory interference, and there was a good separation between cefixime and adjacent impurity and known impurity. The linear relationship between concentration and corresponding peak area of cefixime and all related substances were ideal (r > 0.999 5). The precision, accuracy, and durability of this method were fine. The impurity spectra of 6 batches of self-made preparations and 3 batches of reference preparations of cefixime dispersible tablets were basically consistent, complying with the established quality standards. Conclusion The established method is simple, prompt, and accurate, which can be used to determine the related substances in Cefixime Dispersible Tablets.

R914