HPLC法同时测定7-氨基去乙酰氧基头孢烷酸及其有关物质

Determination of 7-ADCA and its related substances by HPLC

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。

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, 3.5μm ） column with acetonitrile - 80 mmol·L - 1 phosphate buffer solution （ pH 2.5 ） as mobile phase. The detection wavelength was 220 nm. The external stand- ard method and normalization method were used for quantification. Results Under this condition,7 - ADCA were com- pletely separated from impurities and good linearity was observed within measured range （ r 〉 0. 999 ） with the recoveries a- bove 98.1%. Conclusions The method had good specificity, accuracy and precision, and it can he used for the determina- tion of of 7 - ADCA and its related substances.