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LI Long, GUO Wei, YU Xiuli, XIE Chunwen. Determination of the related substances in desloratadine by HPLC[J]. Journal of China Pharmaceutical University, 2019, 50(6): 707-712. DOI: 10.11665/j.issn.1000-5048.20190611
Citation: LI Long, GUO Wei, YU Xiuli, XIE Chunwen. Determination of the related substances in desloratadine by HPLC[J]. Journal of China Pharmaceutical University, 2019, 50(6): 707-712. DOI: 10.11665/j.issn.1000-5048.20190611

Determination of the related substances in desloratadine by HPLC

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  • 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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