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Browse:BritishPharmacopoeia2009
BritishPharmacopoeiaVolumeI&II
Monographs:MedicinalandPharmaceuticalSubstances
DiclofenacSodium

DiclofenacSodium

GeneralNotices



(PhEurmonograph1002)






C14H10Cl2NNaO2318.115307-79-6

Actionanduse

Cyclo-oxygenaseinhibitor;analgesic;anti-inflammatory.

Preparations

Prolonged-releaseDiclofenacCapsules

Gastro-resistantDiclofenacTablets

Prolonged-releaseDiclofenacTablets

PhEur


DEFINITION

Sodium2-[(2,6-dichlorophenyl)amino]phenyl]acetate.

Content

99.0percentto101.0percent(driedsubstance).

CHARACTERS

Appearance

Whiteorslightlyyellowish,slightlyhygroscopic,crystallinepowder.

Solubility

Sparinglysolubleinwater,freelysolubleinmethanol,solubleinethanol(96percent),slightly
solubleinacetone.


©CrownCopyright20061

mp:about280°C,withdecomposition.

IDENTIFICATION

FirstidentificationA,D.

SecondidentificationB,C,D.

A.Infraredabsorptionspectrophotometry(2.2.24).

PreparationDiscs.

ComparisondiclofenacsodiumCRS.

B.Thin-layerchromatography(2.2.27).

TestsolutionDissolve25mgofthesubstancetobeexaminedinmethanolRanddiluteto5
mlwiththesamesolvent.

Referencesolution(a)Dissolve25mgofdiclofenacsodiumCRSinmethanolRanddiluteto
5mlwiththesamesolvent.

Referencesolution(b)Dissolve10mgofindometacinRinreferencesolution(a)anddilute
to2mlwiththesamesolution.


PlateTLCsilicagelGF254plateR.

MobilephaseconcentratedammoniaR,methanolR,ethylacetateR(10:10:80V/V/V).

Application5µl.

DevelopmentOverapathof10cm.

DryingInair.

DetectionExamineinultravioletlightat254nm.

SystemsuitabilityReferencesolution(b):

—thechromatogramshows2clearlyseparatedspots.

ResultsTheprincipalspotinthechromatogramobtainedwiththetestsolutionissimilarin
positionandsizetotheprincipalspotinthechromatogramobtainedwithreferencesolution
(a).

C.Dissolveabout10mgin10mlofethanol(96percent)R.To1mlofthissolutionadd0.2
mlofamixture,preparedimmediatelybeforeuse,ofequalvolumesofa6g/lsolutionof
potassiumferricyanideRanda9g/lsolutionofferricchlorideR.Allo