目的:建立乙胺吡嗪利福异烟片Ⅱ中利福平的有关物质的HPLC方法。方法:色谱柱为Kromasil C_(18)(150 mm×4.6 mm,5μm),流动相为甲醇-磷酸盐缓冲液(55:45),检测波长为254 nm,流速为1.0 ml·min~(-1),柱温40℃,进样量为20μl。结果:共检测到6个杂质峰,各杂质峰与主峰分离度良好。结论:该方法专属性强,稳定性好,灵敏度高,可用于控制乙胺吡嗪利福异烟片Ⅱ的质量。 OBJECTIVE: To establish a HPLC method for the determination of rifampicin related substances in ethylamine pyrazole rifabutin II. METHODS: Kromasil C18 column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase was methanol-phosphate buffer (55:45), the detection wavelength was 254 nm and the flow rate was 1.0 ml · min ~ 1), column temperature 40 ℃, injection volume of 20μl. Results: A total of six impurity peaks were detected. The impurity peaks were separated from the main peaks well. Conclusion: The method is specific, stable and sensitive. It can be used to control the quality of ethylamine pyrazine diferent smoking tablets Ⅱ.