药物中间体5-溴-2-氯-N-环戊胺嘧啶-4-胺的有关物质含量分析方法

Determination of Drug Intermediate 5-bromo-2-chloro-N-cyclopentamine-pyrimidine-4-amine Related Substances Content

建立了5-溴-2-氯-N-环戊胺嘧啶-4-胺高效液相色谱法测定有关物质含量的分析方法。以自身对照,按外标法加校正因子计算有关物质含量。使用Agilent HC-C18色谱柱,流动相为0.1%磷酸和乙腈,梯度洗脱;检测波长240 nm。各杂质在0.025~1.000μg/mL浓度范围内线性关系良好,平均加样回收率在90%~110%,其RSD小于5%。该方法快速、准确,适用于5-溴-2-氯-N-环戊胺嘧啶-4-胺有关物质含量分析方法的检测。

A high performance liquid chromatography method was established for the determination of 5-bromo-2-chloro-N-cyclopentamine-pyrimidine-4-amine related substances content.The content of the relevant substances according to the external standard method plus correction factor with self-comparison was calculated.A Agilent HC-C18 column was used with the mobile phase of 0.1%phosphoric acid and acetonitrile,gradient elution at the detection wavelength of 240 nm.It was linear for impurities in the range of 0.025~1.000μg/mL.The average recovery was between 90%to 110%,and RSD was less than 5%.The method was accurate,fast and suitable for the determination of 5-bromo-2-chloro-N-cyclopentamine-pyrimidine-4-amine related substances content.