HPLC法同时测定7-氨基去乙酰氧基头孢烷酸及其有关物质

目的建立7-氨基去乙酰氧基头孢烷酸(7-ADCA)及其有关物质的含量测定方法。方法采用高效液相色谱法,以Inertsil ODS-3色谱柱(4 mm×150 mm,3.5μm),以乙腈-80 mmol.L-1磷酸盐缓冲液(pH 2.5)为流动相,检测波长为220 nm,外标法和面积归一化法相结合进行定量。结果在该条件下7-ADCA与杂质分离度良好,在测定的范围内均具有良好的线性(相关系数r>0.999),回收率均大于98.1%。结论本方法具有较高的专属性、准确度和精密度,可用于7-ADCA中有关物质和含量的检测。

Determination of 7-ADCA and its related substances by HPLC

Objective To establish an HPLC method for simultaneous determination of of 7-ADCA and its related substances.Methods HPLC was performed on Inertsil ODS-3(4 mm×150 mm,3.5 μm)column with acetonitrile-80 mmol·L-1 phosphate buffer solution(pH 2.5)as mobile phase.The detection wavelength was 220 nm.The external standard method and normalization method were used for quantification.Results Under this condition,7-ADCA were completely separated from impurities and good linearity was observed within measured range(r>0.999)with the recoveries above 98.1%.Conclusions The method had good specificity,accuracy and precision,and it can be used for the determination of of 7-ADCA and its related substances.