HPLC-UV法测定卡培他滨中的对甲苯磺酸酯

Determination of p-toluenesulfonates in Capecitabine by HPLC-UV

建立了高效液相色谱法测定卡培他滨原料药中的基因毒性杂质对甲苯磺酸甲酯(MepTS)、对甲苯磺酸乙酯(EtpTS)和对甲苯磺酸异丙酯(iPrpTS)。采用C18色谱柱(250mm×4.6mm,50μm),紫外检测器在225nm下直接进样测定。三种对甲苯磺酸酯在0.015~0.15μg/mL浓度范围内线性关系良好,定量限均为0.015μg/mL,检测限均为0.005μg/mL,平均回收率在89.2%~100.3%。该方法简单、准确、专属性强且重现性好,适用于卡培他滨中对甲苯磺酸酯基因毒性杂质的测定。

A high performance liquid chromatography method was established for the determination of genotoxic impurities methyl p-toluenesulfonate(MepTS),ethyl p-toluenesulfonate(EtpTS)and isopropyl p-toluenesulfonate(iPrpTS)in capecitabine.A C 18 column(250mm×4.6mm,50μm)was used to separate,and ultraviolet detector was used for direct detection at 225 nm.Calibration curves showed good linearity over the concentration range of 0.015~0.15μg/mL for three p-toluenesulfonates.The limits of quantification were all 0.015μg/mL and the limits of detection were all 0.005μg/mL.The average recoveries were between 89.2%and 100.3%.The established method showed satisfactory convenience,accuracy,specificity and repeatability.This method could be used for the determination of p-toluenesulfonates in capecitabine.