HPLC法测定盐酸帕唑帕尼片含量和有关物质

Content Determination of Main Component and Related Substances in Pazopanib Hydrochloride Tablets by HPLC

目的:建立测定盐酸帕唑帕尼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KromasilC18,流动相为乙腈-0.02mol·L-1醋酸铵缓冲液(35:65),流速为1.0mL·min-1,检测波长为268nm,柱温为25℃,进样量为20μL。结果:盐酸帕唑帕尼检测浓度线性范围为40.18～361.6μg·mL-1(r=0.9999),检测限为2ng,平均回收率为99.60%,RSD=0.53%(n=9)。结论:该方法操作简便、快捷、准确、可靠,可用于盐酸帕唑帕尼片的质量控制。

OBJECTIVE：To develop a method for the content determination of main component and related substances in Pazopanib hydrochloride tablets.METHODS：HPLC method was adopted.The determination was performed on Kromasil C18 column with mobile phase composed of acetonitrile-0.02 mol·L-1 ammonium acetate solution（35：65） at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 268 nm at 25 ℃.The injection size was 20 μL.RESULTS：The linear range of pazopanib hydrochloride was 40.18～361.6 μg·mL-1（r=0.999 9）.The detection limit was 2 ng and average recovery rate was 99.60%（RSD=0.53%,n=9）.CONCLUSION：The method is simple,rapid,accurate and reliable,and it is applicable for the quality control of Pazopanib hydrochloride tablets.