HPLC测定奥格列汀中基因毒性杂质残留量  

Determination of Genotoxic Impurities in Omarigliptin by HPLC

作　　者：郑飞[1] 华国栋[1] 

机构地区：[1]北京中医药大学东方医院药学部,北京100078

出　　处：《中国现代应用药学》2017年第3期396-398,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立奥格列汀原料药中基因毒性杂质的HPLC测定方法。方法采用Zorbax SB-C18色谱柱(250 mm×4.6 mm,5μm),进样量:20μL;流动相为0.1%乙酸水-乙腈(65∶35);流速为1 m L·min^(-1);紫外检测器,检测波长为220 nm;柱温为25℃,色谱乙腈为溶剂。结果该方法专属性良好,测得苯磺酸异丙酯在4~60μg·m L-1内线性关系良好,平均回收率为98.56%(n=9,RSD=3.78%),溶液在8 h内稳定。结论该法操作简便,重复性好,结果准确可靠,可用于奥格列汀原料药中基因毒性杂质的测定。OBJECTIVE To establish an HPLC method to determine genotoxic impurities in omarigliptin bulk drug. METHODS The HPLC was carried out with Zorbax SB-C18 column with the column temperature of 25 ℃. The injection volume was 20 μL. The mobile phase was 0.1% acetic acid water solutiom-acetonitrile（65∶35） with the flow rate of 1 m L·min^-1. The detector was UVD with the detection wave of 220 nm. Acetonitrile was used as solvent for omarigliptin. RESULTS Isopropyl benzenesulfonate could be separated completely with good linear relationship in 4-60 μg·m L-1. The average recovery of isopropyl benzenesulfonate was 98.56%（n=9, RSD=3.78%）. CONCLUSION This method is simple, reproducible and accurate for determination of genotoxic impurities in omarigliptin bulk drug.

关 键 词：奥格列汀 原料药 基因毒性杂质 苯磺酸异丙酯 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]