Determination of the related substances in desloratadine by HPLC
10.11665/j.issn.1000-5048.20190611
- VernacularTitle:HPLC法测定地氯雷他定中的有关物质
- Author:
Long LI
1
;
Wei GUO
;
Xiuli YU
;
Chunwen XIE
Author Information
1. 山东达因海洋生物制药有限公司
- Publication Type:Journal Article
- Keywords:
HPLC;
related substances;
desloratadine;
design of experiments
- From:
Journal of China Pharmaceutical University
2019;50(6):707-712
- CountryChina
- Language:Chinese
-
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.
