HPLC法测定地氯雷他定中的有关物质
Determination of the related substances in desloratadine by HPLC
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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。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.
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Keywords:
- HPLC /
- related substances /
- desloratadine /
- design of experiments
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