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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