HPLC法测定盐酸左旋咪唑中有关物质

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,5 μm);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10 μl.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1.11～11.10 μg·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.

Determination of Related Substances in Levamisole Hydrochloride by HPLC

Objective： To establish an HPLC method for the determination of the related substances in levamisole hydrochloride.Method： The column was Aichrombond C18（250 mm×4.6 mm,5 μm）,the mobile phase consisted of 0.5% ammonium dihydrogen phosphate（adjusting pH to 6.5 with triethylamine）-acetone（70∶ 30） at the flow rate of 1.0 ml·min-1,the detection wavelength was 215 nm and the injection volume was 10 μl.Result： The linear range of 2,3-dihydrogen-6-phenylimidazol thiazoli hydrochloride was 1.11~11.10 μg·ml-1（r=0.998 5）,and the detection limit was 0.6 ng.Conclusion： The method is specific and reproducible for the determination of the related substances in levamisole hydrochloride.