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 Luna C18,流动相为0.01 mol·L-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.μg·mL-1(γ=0.999 9);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.
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