目的 建立地拉罗司原料药含量及有关物质测定的反相高效液相色谱法.方法 色谱柱为Phenomenex C1 8(250mm×4.6mm,5μm),以A[EDTA缓冲液-水-乙腈(100:800:100)]-B[EDTA缓冲液-乙腈(100:900)](100g EDTA,加1000mL水,加磷酸调节pH至2.10±0.10)为流动相进行梯度洗脱,检测波长303nm,流速1.0mL/min,柱温60℃.地拉罗司与相关物质及其降解产物分离度良好.结果 地拉罗司在15.00～41.70μg/mL与峰面积呈良好的线性关系(Y=2.8920X+11.939,R2=0.9995,n=6),回收率在98.5％～100.8％ (RSD＜1.0％,n=3).结论 该方法简便快速、准确灵敏、重复性好,能够用于地拉罗司含量及有关物质测定.%Objective To establish a RP-HPLC method for the determination of the content and related substances of the deferasirox raw material.Methods Phenomenex C18 (250mm×4.6mm,5μm) column was used.The mobile phase consisted of [EDTA buffer-water-acetonitrile (100:800:100)] as the mobile phase A and [EDTA buffer-acetonitrile (100:900)] (100g EDTA,plus 1000mL water,and use phosphoric acid to adjust pH to 2.10±0.10) as the mobile phase B.Gradient elution was used.The detective wave length is 303nm.The flow rate was 1.0mL/min.The column temperature was 60℃.The injection volume was 20μL.Results The separation among deferasirox,related impurities and degradation products was good.There was a good linear relationship between the peak area and concentration at 15.00～41.70μg/mL (R2=0.9995,n=6),and the recovery rate was at 98.50％～100.80％ (RSD＜1.0％,n=3).Conclusion The method is sensitive,exclusive,accurate and suitable for the determination of deferasirox and related substances.
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