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目的:建立高效液相色谱法测定盐酸左旋咪唑中的有关物质。方法:色谱柱为Aichrombond C18(250 mm×4.6 mm,5μm);流动相为0.5%磷酸二氢铵(用三乙胺调节pH至6.5)-乙腈(70∶30);流速为1.0 ml.min-1;检测波长为215 nm;进样量为10μl。结果:有关物质各杂质峰与主峰之间分离良好,杂质2,3-二氢-6-苯基咪唑[2,1-b]噻唑盐酸盐的线性范围为1.11～11.10μg.ml-1(r=0.998 5),最低检测限为0.6 ng。结论:该方法专属性强、重复性好,可用于盐酸左旋咪唑的有关物质测定。
Objective: To establish a method for the determination of related substances in levamisole hydrochloride by high performance liquid chromatography. Methods: The chromatographic column was Aichrombond C18 (250 mm × 4.6 mm, 5 μm). The mobile phase was 0.5% ammonium dihydrogen phosphate (adjusted to pH 6.5 with triethylamine) -acetonitrile (70:30) at a flow rate of 1.0 ml · min -1; detection wavelength of 215 nm; injection volume of 10μl. Results: The separation of impurity peaks from the main peak was good. The linear range of impurity 2,3-dihydro-6-phenylimidazo [2,1-b] thiazole hydrochloride was 1.11-11.11μg.ml-1 (r = 0.998 5), the minimum detection limit was 0.6 ng. Conclusion: The method is highly specific and reproducible. It can be used for the determination of levamisole hydrochloride.