HPLC法测定维格列汀片中主药和有关物质的含量

Content Determination of Main Components and Related Substances in Vildagliptin Tablets by HPLC

目的:建立测定维格列汀片中主药和有关物质含量的方法。方法:采用高效液相色谱法。色谱柱为Phenomenex LunaC18,流动相为0.01mo·lL-1磷酸氢二钾溶液-乙腈(75∶25),流速为1.0mL·min-1,检测波长为210nm,进样量为20μL。结果:维格列汀检测浓度的线性范围为25.0～225.0μg·mL-1(r=0.9999);平均回收率为99.60%(RSD=0.77%)。3批样品中主药标示含量分别为99.46%、98.94%、99.61%,有关物质含量分别为0.37%、0.22%、0.56%。结论:本方法操作简便、快捷,结果准确、可靠,可用于维格列汀片的质量控制。

OBJECTIVE：To establish a method for the determination of the vildagliptin and the related substances in Vildagliptin tablets.METHODS：HPLC method was adopted.The determination was performed on Phenomenex Luna C18 with mobile phase consisted of 0.01 mol·L-1 dipotassium hydrogen phosphate solution-acetonitril（75 ∶ 25） at flow rate of 1.0 mL·min-1.The detection wavelength was set 210 nm and the sample size was 20 μL.RESULTS：The linear range of vildagliptin was 25.0～225.0 μg·mL-1（r=0.999 9） with an average recovery of 99.60%（RSD=0.77%） .The labeling amounts of main components of 3 batches of samples were 99.46%,98.94% and 99.61%.The contents of relevant substances were 0.37%,0.22%,0.56%.CONCLUSIONS：The method is simple,rapid,accurate and reliable,and it is applicable for the quality control of Vildagliptin tablets.