高效液相色谱法测定替格瑞洛原料药中基因毒性杂质的含量  

Determination of Genotoxic Impurity in Bulk Drug of Ticagrelor by HPLC

作　　者：蔡丽朋 周琪 CAI Li-peng;ZHOU Qi(Jiangxi Qingfeng Pharmaceutical Ltd,Ganzhou 341000,China)

机构地区：[1]江西青峰药业有限公司,江西赣州341000

出　　处：《海峡药学》2022年第5期53-56,共4页Strait Pharmaceutical Journal

摘　　要：目的建立替格瑞洛原料药中基因毒性杂质N的测定方法。方法采用高效液相色谱(HPLC),选用C_(18)色谱柱(Agilent Zorbax SB C_(18),150 mm×4.6 mm,5μm),乙腈为流动相A,磷酸盐缓冲液为流动相B,梯度洗脱,流速1.0 mL·min^(-1),检测波长210 nm,柱温35℃。结果上述色谱条件下,基因毒性杂质N与其他组分分离完全;在0.0107~0.0485μg·mL^(-1)浓度范围内,峰面积(A)与杂质N浓度(C)有良好的线性关系,回归方程为A=40722C+9.9875(r=0.9996),平均回收率为99.8%,RSD为0.61%。结论该方法稳定、可靠、重现性好,可用于替格瑞洛原料药中基因毒性杂质N的含量测定。OBJECTIVE To develop an method for determination of the genotoxic impurity N in bulk drug of ticagrelor.METHODS The determination was performed by HPLC on a C_(18) column(Aglient Zorbax SB C_(18),150 mm×4.6 mm,5μm)with acetonitrile as mobile phase A and phosphate buffer solution as the mobile phase B by gradient elution.The flow rate was 1.0 mL·min^(-1),the detection wavelength was 210 nm,and the column temperature was kept at 35℃.RESULTS The peak of impurity N and other components could be separated well.There was a good linear relationship between peak area(A)and impurity N concentration(C)in the concentration range of 0.0107-0.0485μg·mL^(-1).The regression equation was A=40722 C+9.9875(r=0.9996),the average recovery was 99.8%and the RSD was 0.61%.CONCLUSION The method is stable,reliable and reproducible and can be used in the determination of the genotoxic impurity N in bulk drug of ticagrelor.

关 键 词：替格瑞洛 原料药 基因毒性杂质 高效液相色谱法 含量测定 

分 类 号：R927[医药卫生—药学]