OBJECTIVE:To establish a method for the content determination of cabozantinib in its raw material. METHODS:RP-HPLC method was adopted. The determination was performed on Inertsil ODS-SP C18 column with mobile phase consisted of acetonitrile-0.02 mol/L ammonium acetate buffer (pH 5.2,52:48,V/V) at the flow rate of 1.0 mL/min. Detection wavelength was set at 241 nm,the column temperature was 38 ℃,and sample size was 20 μL. RESULTS:The linear range of cabozantinib were 9.88-49.40 μg/mL(r=0.9999). The limit of quantitation was 11.46 ng,and the limit of detection was 3.36 ng. The RSDs of preci-sion,stability,repeatability tests were all lower than 2.0%;recoveries were 98.5%-101.7%(RSD=1.2%,n=9). CONCLU-SIONS:The method is simple,accurate and suitable for the content determination of cabozantinib in its raw material.%目的:建立测定卡博替尼原料药中卡博替尼含量的方法.方法:采用反相高效液相色谱法.色谱柱为Inertsil ODS-SP C18,流动相为乙腈-0.02 mol/L乙酸铵缓冲溶液(pH 5.2)(52:48,V/V),流速为1.0 mL/min,检测波长为241 nm,柱温为38℃,进样量为20μL.结果:卡博替尼检测质量浓度线性范围为9.88~49.40μg/mL(r=0.9999);定量限为11.46 ng,检测限为3.36 ng;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为98.5~101.7%(RSD=1.2%,n=9).结论:该方法操作简便、结果准确,可用于卡博替尼原料药中卡博替尼的含量测定.
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