Determination of Related Substances in Gatifloxacin Mesylate for Injection by HPLC
- VernacularTitle:高效液相色谱法测定注射用甲磺酸加替沙星的有关物质
- Author:
Jing TIAN
- Publication Type:Journal Article
- Keywords:
HPLC;
Gatifloxacin mesilate for injection;
Related substances
- From:
Journal of Medical Research
2006;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish HPLC method for determination of the related substances in gatifloxacin mesylate for injection.Methods Determination was performed with C18(150mm?4.6mm,5?m)as the chromatographic column.The mobile phase was consisted of phosphoric acid-acetonitrile(82:18)with a flow rate at 1.0ml/min.The column temperature was 30℃ and the detection wavelength was 325nm.Results Good linear relation was achieved when the gatifloxacin concentration was at the range of 78.8～630.4?g/ml(r=0.9999).All the chief peaks of gatifloxacin and those of their related substances were well isolated in all the specificity tests.the detective limit was 0.038?g/ml(S/N=4).the total peak area of therelated substances of all batches of samples was not more 1% of the peak area of their solutions.Conclusions This method is simple,accurate and stable.
