RP-HPLC法测定凡德他尼片中主药和有关物质的含量

Content Determination of Main Components and Related Substances in Vandetanib Tablets by RP-HPLC

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 content determination of main components and related substances in Vandetanib tablets. METHODS： RP-HPLC method was adopted. The determination was performed on Kromasil C18 column with mobile phase consisted of 0.05 mol·L^-1 acetate buffer-methanol （30：70, adjusting pH to 8.0） at the flow rate of 1.0 mL·min^-1. The detection wavelength was set at 247 nm and injection volume was 20 μL. RESULTS： The linear range of vandetanib was 20.05-180.4μg·mL^-1（r=0.999 9） with an average recovery of 99.40% （RSD=0.56%）, and LOQ was 4 ng. CONCLUSION： The method is simple, rapid, accurate and reliable, and it is applicable for the quality control of Vandetanib tablets.