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目的:建立高效液相色谱测定恩曲他滨中有关物质的方法。方法:采用Inertsil C8色谱柱(250 mm×4.6 mm,5μm),以缓冲液(取10%四丁基氢氧化铵溶液2.0 g,用0.013 mol.L-1磷酸二氢钠溶液稀释至1000 mL)-乙腈(85∶15)为流动相(用磷酸调节pH至5.0),流速为1.0 mL.min-1,检测波长为220 nm。结果:杂质峰与主峰均分离良好。结论:该法专属性强、准确、灵敏,可用于恩曲他滨原料中有关物质的检查。
Objective: To establish a method for the determination of related substances in emtricitabine by high performance liquid chromatography. METHODS: Inertsil C8 column (250 mm × 4.6 mm, 5 μm) was used in the buffer solution (taking 2.0 g of 10% tetrabutylammonium hydroxide solution and diluting to 1000 mL with 0.013 mol·L -1 sodium dihydrogenphosphate solution) Acetonitrile (85:15) as the mobile phase (adjusted to pH 5.0 with phosphoric acid) at a flow rate of 1.0 mL.min-1 at a detection wavelength of 220 nm. Results: The impurity peak and the main peak are well separated. Conclusion: The method is highly specific, accurate and sensitive and can be used for the determination of related substances in emtricitabine raw materials.