Determination of Principal Agents and the Related Substances of Compound Ftibamzone/Dyclonine Liniment by HPLC
- VernacularTitle:HPLC法测定复方酞丁安/达克罗宁搽剂中主药及有关物质的含量
- Author:
Zhihong LI
;
Yongliang GAO
- Publication Type:Journal Article
- Keywords:
HPLC;
Compound ftibamzone/dyclonine liniment;
Content determination;
Related substances
- From:
China Pharmacy
2007;0(34):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a HPLC method for determination of the principal components and the related substances in compound ftibamzone/dyclonine liniment. METHODS: The determination was performed on MACHEREY-NAGEL C18 chromatographic column with the mobile phase consisted of methanol-acetonitrile-0.02 mol?L-1 potassium dihydrogen phosphate solution-triethylamine (25∶25∶50∶0.3,pH value adjusted to 4.0 by the phosphoric acid) with a flow rate of 1.0 mL?min-1. The UV detection wavelength was set at 295 nm. RESULTS: A baseline separation was achieved between foreign materials’ peaks and the principal agents’ peaks. The calibration curve of ftibamzone and dyclonine were linear within the ranges of 20.63～72.21 ?g?mL-1(r=0.999 9) and 20.44～71.54 ?g?mL-1 (r=0.999 9),respectively;the average recovery rate was 98.7% vs. 99.2%;the inter-day RSD was 0.97% vs. 1.10%;the intra-day RSD was 1.52% vs. 1.75%,and the lowest detective limit was 0.4 ng vs. 0.2 ng. The contents of the related substances were ranged from 0.43% to 0.68%. CONCLUSION: This method is simple,rapid,specific,accurate and reproducible,and it can be used for the quality control of the compound ftibamzone/dyclonine liniment.
