中国药科大学学报2017，Vol.48Issue(3)：322-327,6.DOI:10.11665/j.issn.1000-5048.20170312
HPLC法测定甲磺酸奥希替尼的含量
Determination of osimertinib mesylate by HPLC
周平 1李莉 1武路路 1顾辰昊 1田会敏 1任小明 2张海军 1吴家权1
作者信息
- 1. 无锡佰翱得生物科学有限公司,江阴214437
- 2. 南京工业大学应用化学系,南京210009
- 折叠
摘要
Abstract
To establish an HPLC method to determine osimertinib mesylate,Agilent ZORBAX Eclipse Plus C18 column (4.6 mm × 250 mm,5 μm) was used with a mobile phase consisting of methanol-buffer solution (20 mmoL/L NaH2PO4,pH 3.0 adjusted with 85％ H3PO4) (50 ∶ 50) at the flow rate of 1.0 mL/min.The detection wavelength was 210 nm,and the column temperature was kept at 35 ℃.The calibration curve was liner over the range from 50％ to 150％ of determination concentration (0.201 1-0.603 2 mg/mL,r =0.999 9).The limit of quantitation (LOQ) and limit of detection (LOD) were 0.32 μg/mL and 0.08 μg/mL,respectively.The contents of osimertinib mesylate in samples were 100.1％,99.5％ and 99.7％.Good chromatographic separation of osimertinib mesylate and its related substances,including synthetic impurities and degradation products,were obtained.The established HPLC method is specific,accurate,simple and durable,and could be used for the determination of osimertinib mesylate.关键词
甲磺酸奥希替尼/高效液相色谱/含量测定/有关物质Key words
osimertinib mesylate/HPLC/determination/related substances分类
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周平,李莉,武路路,顾辰昊,田会敏,任小明,张海军,吴家权..HPLC法测定甲磺酸奥希替尼的含量[J].中国药科大学学报,2017,48(3):322-327,6.
