Determination of diclofenac sodium and related compounds in raw materials and formulations.
A liquid chromatographic method has been developed for determination of drug and related compounds in diclofenac sodium raw material, slow-release, and enteric coated tablets. The method specifies a 5 microns octadecylsilane bonded phase column, a mobile phase of tetrahydrofuran-acetonitrile-buffer, pH 5 (1 + 4 + 8.3), and detection at 229 nm. The method resolves 10 known related compounds with limits of quantitation of 0.2% or less. Seventeen drug raw material samples were evaluated. Total impurity levels ranged from 0.1 to 0.9%. The method has also been used for determination of drug content in raw materials and formulations. Mean assay levels in drug raw materials ranged between 98.3% and 101.8%.
Beaulieu
N
N
Bureau of Drug Research, Health Protection Branch, Ottawa, Ontario, Canada.
Lovering
E G
EG
Lefrançois
J
J
Ong
H
H
D002853:Chromatography, Liquid; D004008:Diclofenac / Q000031:analogs & derivatives / Q000032:analysis*; D007202:Indicators and Reagents; D009682:Magnetic Resonance Spectroscopy; D013055:Spectrophotometry, Infrared; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013608:Tablets, Enteric-Coated
D007202:Indicators and Reagents; D013607:Tablets; D013608:Tablets, Enteric-Coated; D004008:Diclofenac