RP-HPLC法测定卡博替尼原料药中卡博替尼的含量
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篇名: RP-HPLC法测定卡博替尼原料药中卡博替尼的含量
TITLE:
摘要: 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20 μL。结果:卡博替尼检测质量浓度线性范围为9.88~49.40 μg/mL(r=0.999 9);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。
ABSTRACT: 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=0.999 9). The limit of quantitation was 11.46 ng, and the limit of detection was 3.36 ng. The RSDs of precision, stability, repeatability tests were all lower than 2.0%; recoveries were 98.5%-101.7% (RSD=1.2%,n=9). CONCLUSIONS: The method is simple, accurate and suitable for the content determination of cabozantinib in its raw material.
期刊: 2017年第28卷第12期
作者: 徐伟,詹长娟,王华,王翼,郭琪
AUTHORS: XU Wei,ZHAN Changjuan,WANG Hua,WANG Yi,GUO Qi
关键字: 卡博替尼;反相高效液相色谱法;含量测定
KEYWORDS: Cabozantinib; RP-HPLC; Content determination
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