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目的:建立测定凡德他尼片中主药和有关物质含量的方法。方法:采用反相高效液相色谱法。色谱柱为KromasilC18,流动相为0.05mol·L-1醋酸铵缓冲液-甲醇(30∶70,pH8.0),流速为1.0mL·min-1,检测波长为247nm,进样量为20μL。结果:凡德他尼检测浓度的线性范围为20.05～180.4μg·mL-(1r=0.9999);平均回收率为99.40%(RSD=0.56%),定量限为4ng。结论:本方法操作简便、快捷,结果准确、可靠,可用于凡德他尼片的质量控制。
Objective: To establish a method for the determination of the main drug and related substances in vandetanib tablets. Methods: Reversed-phase high performance liquid chromatography. The chromatographic column was Kromasil C18, the mobile phase was 0.05 mol·L-1 ammonium acetate buffer-methanol (30:70, pH 8.0), the flow rate was 1.0 mL · min-1, the detection wavelength was 247 nm and the injection volume was 20 μL. Results: The linear range of vandetanib was 20.05-180.4μg · mL- (1r = 0.9999). The average recovery was 99.40% (RSD = 0.56%) and the limit of quantification was 4ng. Conclusion: The method is simple, rapid, accurate, reliable and can be used for the quality control of vandetanib tablets.