氯法拉滨的有关物质检查及其含量测定研究

Determination of Clofarabine and Its Related Substances

目的建立氯法拉滨原料有关物质检查及含量测定的高效液相色谱法为原料的质量控制提供有效的分析方法。方法采用Diamonsil C18(4.6mm×250mm,5μm)柱;流动相:乙腈-水(乙酸调pH至4.0)=16∶84;检测波长:263nm;流速:1.0mL.min-1;柱温:30℃。结果在所选定的色谱条件下,氯法拉滨与有关物质均能分离完全;氯法拉滨在1～100mg·L-1内,峰面积与浓度线性关系良好,r=0.9999;检测限为0.004ng。结论方法简便,准确,专属性强,可用于氯法拉滨原料的有关物质检查及含量测定。

OBJECTIVE To develop a HPLC method for the determination ofclofarabine and its related substances for quality control. METHODS The separation was carried out on a Diamonsil C18 column （4.6 mm×250 ram, 5 μm）, using a mixture of acetonitrile-water （pH 4.0 adjusted by acetic acid）-16：84 as the mobile phase at a flow rate of 1.0 mL·min^-11.The ultraviolet detection wavelength was set at 263 nm, the column temperature was 30 ~C. RESULTS Under the established chromatographic conditions, clofarabine and the related substances were separated completely. The standard curve was linear within the range of 1-100 mg·L^-1 with the correlation coefficient of 0.999 9, the limit of detection was 0.004 ng. CONCLUSION The established method was simple, accurate, specific and could be used for quality control of clofarabine.