Determination of Related Substances in Enoxacin Gluconate Injection by HPLC with Gradient Elution / 中国药师
China Pharmacist
; (12): 936-938,939, 2015.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-671142
Responsible library:
WPRO
ABSTRACT
Objective:
To establish a method for the determination of related substances in enoxacin gluconate injection by HPLC with gradient elution.Methods:
HPLC was performed on a DiamonsilTM C18 column (250 mm × 4. 6 mm, 5 μm), the mobile phase A was 0. 025 mol·L-1 phosphonic acid solution (adjusting pH to 3. 0 with triethylamine)-methanol- acetonitrile (80∶10∶10) and the phase B was 0. 025 mol·L-1 phosphonic acid solution (adjusting pH to 3. 0 with triethylamine)-methanol-acetonitrile (350∶325∶325) with gradient elution at a flow rate of 1. 1 ml·min-1 , the detection wavelength was 269 nm and 284 nm, the injection volume was 20μl, and the column temperature was 40℃.Results:
Under the HPLC conditions, the samples had good stability and separation. The calibration curve was linear within the concentration range of 19. 80 ng·ml-1-19. 80 μg·ml-1(r=0. 999 9) for 5-hydroxymethylfur-fural with the detection limit of 0. 18ng, and the average recovery was 99. 68% with RSD of 0. 12% (n=9).Conclusion:
The method is accurate, sensitive, specific and reproducible, and can be used in the determination of related substances in enoxacin gluconate in-jection.
Full text:
Available
Database:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacist
Year:
2015
Document type:
Article