维格列汀原料药有关物质测定方法的研究

Yan HUANG,Xuefeng YANG,Xueyun CHEN,Naiguang FU,Nian'gen CHEN,Xia ZHONG

China Medicine and Pharmacy（2017）

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Abstract

目的建立高效液相色谱法测定维格列汀原料药的有关物质.方法采用Waters XTerra MS C18柱(4.6mm×50mm,3.5μm),以磷酸盐缓冲液-水-乙腈-甲醇(80:120:3:3)为流动相A,以磷酸盐缓冲液-乙腈-甲醇(8:9:3)为流动相B,梯度洗脱,检测波长为210nm;流速1.5mL/min.结果维格列汀与相邻杂质峰以及各杂质峰之间的分离度均大于1.3,检测限为1.2~1.6ng,定量限为2.4~3.3ng.结论该方法适用于维格列汀关物质的测定.

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