Objective To establish an HPLC method for the determination of related substances in rifalazil. Methods Separation was performed on a Diamonsil-C18 column (250mm×4.6mm, 5μm), the column temperature was maintained at 55V. The mobile phase was 0.02mol/L citrate buffer solution(containing 0.lmol/L sodium perchlorate, adjust pH to 2.8)-acetonitrile(35:65, VIV). The flow rate was l.0mL/min. The detection wavelength was 230nm. The injection volume was l0μL. Results Rifalazil was completely separated from related substances. The calibration curve was linear within 1.05-787.80μg/mL with a correlation coefficient of 1.0000 for rifalazil. The lowest limit of detection was 0.4ng for rifalazil. Conclusion This method was fast, selective, accurate and reliable, can be used for the determination of related substances of rifalazil.%目的 建立高效液相色谱法测定利福拉齐的有关物质.方法 采用Diamonsil C18色谱柱(250mm×4.6mm,5μm),以0.02mol/L柠檬酸缓冲液(含0.1mol/L NaClO4,pH2.8)-乙腈(35∶65,V/V)为流动相,流速为1mL/min,检测波长为230nm,柱温为35℃,进样体积为10μL.结果 利福拉齐与各有关物质分离良好:利福拉齐在1.05～787.80μg/mL浓度范围内,峰面积与浓度呈良好的线性关系,相关系数为1.0000,利福拉齐的检测限为0.4ng.结论 该方法快速、专属、准确、可靠,可用于利福拉齐有关物质的测定.
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