抗癌新药伊立替康含量测定方法的研究

Studies on Determination of New Anticancer Drug Irinotecan

目的 :建立反相高效液相色谱法测定抗癌新药伊立替康的含量。方法 :采用外标法 ,色谱柱为AlltimaC18柱 ( 5μm ,2 50mm× 4 6mm) ;流动相为乙腈 -pH 4 0的 0 1mol·L- 1磷酸氢二钾缓冲液 ( 2 58∶74 2 ,含 2 5 7mmol·L- 1三乙胺 ) ;检测波长为 2 54nm ;流速为 1 0mL·min- 1。结果 :伊立替康浓度与峰面积具有良好相关性 ,线性范围为 1 96～ 9 80 μg·mL- 1,r =0 9998,精密度RSD为 0 73 % ,平均回收率为 ( 99 83± 0 95) % ,最低检测限为 1 0ng·mL- 1。结论 :该方法灵敏 ,准确 。

Objective:RP-HPLC methods were developed for the determination of Irinotecan,a water soluble derivative of camptothecin,with potent anticancer activity Method:An Alltima C 18 column was used and a UV detector was set at 254 nm The mobile phase was a mixture of acetonitrile-0 1 mol·L -1 phosphate buffer solution(pH 4 0)containing 25 6 mmol·L -1 triethylamine(258∶742) The flow rate was 1 0 mL·min -1 Results:The linear range was 1 96～9 80 μg·m -1 and the correlation coefficient was 0 999 8,the RSD of injection was 0 73%,the average recovery of the method was 99 83%,the lower limit of determination was 10 ng·mL -1 Conclusion:The method is accurate,sensitive and reliable