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目的采用HPLC法测定盐酸头孢替安中的有关物质。方法色谱柱为Agilent C18柱(250 mm×4.6 mm,5μm),流动相为0.05 mol·L-1磷酸氢二钠(p H7.2)-乙腈(88∶12),流速为1 m L·min-1,检测波长为254 nm。结果各已知杂质间的分离度良好,精密度及耐用性均符合要求。结论所用方法专属性强、结果准确,可用于盐酸头孢替安中有关物质的检查。
Objective To determine the related substances in cefotiam hydrochloride by HPLC. METHODS The column was Agilent C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of 0.05 mol·L -1 disodium hydrogen phosphate (p H 7.2) -acetonitrile (88:12) at a flow rate of 1 mL min-1, the detection wavelength is 254 nm. The results of the known impurities between the good separation, precision and durability are in line with the requirements. Conclusion The method used is specific and accurate and can be used for the determination of related substances in cefotiam hydrochloride.