Determination of related substances in fluconazole bulk drug / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 1333-1336, 2012.
Article
in Chinese
| WPRIM
| ID: wpr-860652
ABSTRACT
OBJECTIVE:
To establish an HPLC gradient elution method for the determination of related substances in fluconazole bulk drug.METHODS:
The separation was achieved by using an ODS column with gradient elution of mobile phase composed of 0.01 mol · L-1 ammonium formate and acetonitrile. The flow rate was 0.5 mL · min-1. The UV detection wavelength was 261 nm, injection volume is 20 μL.RESULTS:
Fluconazole and its related substances can be separated effectively by this method, linear relation of fluconazole and impurity B-D were good, the detection limit were 0.20, 0.0052, 0.0073, 0.13 μg · mL-1, seventeen batches sample from nine manufacturers were determined. The related substances in fluconazole bulk drug were effectively determined.CONCLUSION:
The HPLC method is rapid and accurate which may be used for the inspection of related substances in fluconazole bulk drug. Copyright 2012 by the Chinese Pharmaceutical Association.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2012
Type:
Article
Similar
MEDLINE
...
LILACS
LIS