Determination of Related Substance in Cloperastine Hydrochloride by HPLC
- VernacularTitle:HPLC法测定盐酸氯哌丁原料药的有关物质
- Author:
Zhenqiang GAO
- Publication Type:Journal Article
- Keywords:
HPLC;
Cloperastine hydrochloride;
Related substance
- From:
China Pharmacy
2005;0(22):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To determine the related substance in cloperastine hydrochloride by HPLC.METHODS:The analysis was conducted on Agilent C18 column with the mobile phase consisted of 0.02 mol?L-1 KH2PO4-methanol(30∶70,triethlaminel 1.0 mL,adjusted to pH=3.5 with phosphoric acid) at a flow rate of 1.0 mL?min-1.The detection wavelength was 225 nm;the column temperature was set at room temperature,and the injection volume was 20 ?L.RESULTS:Effective segregation was achieved for the related substance from the chief chromatographic peak.The total peak area of the related substance in the sample was 0.13%～0.26% that of the main constituent of its reference substance(own control solution).CONCLUSION:The method is simple,accurate and specific,and applicable for the quality control of the related substance in cloperastine hydrochloride.
