摘要
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.
作者
李龙
郭伟
于秀丽
解春文
LI Long;GUO Wei;YU Xiuli;XIE Chunwen(Shandong Dyne Marine Biopharmaceutical Co.,Ltd.,Shandong 264300,China)
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2019年第6期707-712,共6页
Journal of China Pharmaceutical University