UPLC法测定醋酸阿比特龙吡啶基位置异构体

Determination of Pyridyl Position Isomers of Abiraterone Acetate by UPLC

建立超高效液相色谱法测定醋酸阿比特龙的2位和4位吡啶基位置异构体。该方法使用的色谱柱为:Waters Cortecs UPLC C18(100 mm×2.1 mm,1.6μm)。以0.1%甲酸水溶液(含0.01 mol/L氯化铵)为流动相A、乙腈为流动相B、甲醇为流动相C,流速为0.4 mL/mim,进行线性梯度洗脱。检测波长为210 nm,柱温为40℃,进样量为2μL。2个位置异构体的定量限均为0.0375μg/mL,在0.1875~0.9375μg/mL范围内的线性关系良好。2-吡啶基异构体的平均回收率为101.4%,RSD为2.7%;4-吡啶基异构体的平均回收率为98.1%,RSD为2.2%。本方法操作简便,有良好的专属性和灵敏度,可用于醋酸阿比特龙的质量控制。

An ultra-high performance liquid chromatography method was established for the determination of the 2-and 4-pyridyl positional isomers of abiraterone acetate.The column used in this method is:Waters Cortecs UPLC C18(100 mm×2.1 mm,1.6μm).Using 0.1%formic acid aqueous solution(containing 0.01 mol/L ammonium chloride)as mobile phase A,acetonitrile as mobile phase B,and methanol as mobile phase C,the flow rate was 0.4 mL/min,and linear gradient elution was performed.The detection wavelength is 210 nm,the column temperature is 40℃,and the injection volume is 2μL.The quantification limits of the two positional isomers are both 0.0375μg/mL,and the linear relationship is good in the range of 0.1875 to 0.9375μg/mL.The average recovery rate of 2-pyridyl isomer was 101.4%,and the RSD was 2.7%;the average recovery rate of 4-pyridyl isomer was 98.1%,and the RSD was 2.2%.This method is simple to operate,has good specificity and sensitivity,and can be used for the quality control of abiraterone acetate.