HPLC法测定地氯雷他定中的有关物质

Determination of the related substances in desloratadine by HPLC

通过实验设计建立地氯雷他定原料有关物质检测方法。确定最优色谱条件为:ODS柱(4.6 mm×250 mm,4μm);检测器:UV检测器;检测波长:280 nm;柱温:35℃;流动相流速:1.5 mL/min;进样体积:40μL;流动相:乙醇-0.003 mol/L十二烷基硫酸钠水溶液(47∶53),建立了地氯雷他定有关物质检测方法,可同时对工艺杂质及降解杂质进行检测。本方法简单、可靠,可准确检测地氯雷他定中有关物质含量,为地氯雷他定的质量控制提供理论依据。

Established liquid chromatographic method for determination of desloratadine and its impurities by DOE.The separation was achieved by using a reversed phase chromatographic column(ODS,250 mm×4.6 mm,4 μm) with gradient eluent composed of ethanol-0.003 mol/L sodium dodecyl sulfate aqueous solution(dissolve 0.570 sodium dodecyl sulfate in water,add 0.5 mL trifluoroacetic acid and dilute to 1 000 mL with water)(43 ∶57) at a wavelength of 280 nm.The sample size was 40 μL,column temperature was set at 35 ℃ and flow rate of mobile phase was 1.5 mL/min.A method for determination of desloratadine and its impurities of process and degration was established.The developed method is sensitive,convenient,and can control the drug quality efficiently.