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HPLC法测定地氯雷他定中的有关物质
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引用本文:李龙,郭伟,于秀丽,解春文.HPLC法测定地氯雷他定中的有关物质[J].中国药科大学学报,2019,50(6):707-712.
Cite:LI Long,GUO Wei,YU Xiuli,XIE Chunwen.Determination of the related substances in desloratadine by HPLC[J].J China Pharm Univ,2019,50(6):707-712.
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作者单位
李龙 山东达因海洋生物制药有限公司 
郭伟 山东达因海洋生物制药有限公司 
于秀丽 山东达因海洋生物制药有限公司 
解春文 山东达因海洋生物制药有限公司 
中文摘要: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,4 μm);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:40 μL;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。
中文关键词:高效液相色谱法  地氯雷他定  有关物质  含量测定  实验设计
 
Determination of the related substances in desloratadine by HPLC
Abstract: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 °C 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.
keywords:HPLC  related substances  desloratadine  design of experiments
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