HPLC法测定恩杂鲁胺原料药的含量

Determination of enzalutamide crude drug by HPLC

为建立HPLC法测定恩杂鲁胺原料药的含量,采用Ultimate LP-C18(250×4.6 mm,5μm)色谱柱,以甲醇-0.1%磷酸二氢钾溶液(70∶30)为流动相,流速为1.0 m L/min,进样量为10μL.结果表明,恩杂鲁胺的浓度在12 52μg/m L范围内与峰面积呈现良好的线性关系(r=0.999 2),平均回收率为99.18%100.10%(n=3),RSD为0.4%0.5%.本法具有分析速度快、简单、准确以及专属性强好等特点,适合恩杂鲁胺含量的测定.

To establish an HPLC method for the determination of the content of enzalutamide crude drug.Ultimate LP-C18 column（ 250 × 4. 6 mm,5 μm） was used. The mobile phase was methonal-0. 1% potassium dihydrogen phosphate solution（ 70 ∶ 30）. The flow rate was 1. 0 m L·min^-1. The injection volume was 10 μL.The results showed that there was good linearity of enzalutamide in the range of 12—52 μg/m L（ r = 0. 999 2）.The average recovery was 99. 18% —100. 10%（ n = 3）,and RSD was 0. 4% —0. 5%. The method was rapid,simple,accurate and specific for the content determination of enzalutamide.