阿托伐他汀钙欧洲药典

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1、AtorvastatincalciumtrihydrateEUROPEANPHARMACOPOEIA7.1Column:—size:l=0.25m,Ø=4.6mm;—stationaryphase:amylosederivativeofsilicagelforchromatographyR(10μm).Mobilephase:trifluoroaceticacidR,anhydrousethanolR,J.methyl3-[[(2RS)-2-bromopropanoyl]amino]-4-hexaneR(0.1:6:94V/V/V).methylthiophene-2-carboxylate(

2、bromocompound).Flowrate:1.0mL/min.Detection:spectrophotometerat244nm.04/2011:2191Injection:20μL.ATORVASTATINCALCIUMTRIHYDRATERuntime:1.2timestheretentiontimeofatorvastatin.Relativeretentionwithreferencetoatorvastatin(retentionAtorvastatinumcalcicumtrihydricumtime=about44min):impurityE=about0.8.Syste

3、msuitability:referencesolution(a):—resolution:minimum2.0betweenthepeaksduetoimpurityEandatorvastatin.Limit:—impurityE:notmorethantheareaoftheprincipalpeakinthechromatogramobtainedwithreferencesolution(b)(0.3percent).Relatedsubstances.Liquidchromatography(2.2.29).Testsolution(a).Dissolve40.0mgofthesu

4、bstancetobeCHCaFNO,3HOM1209666824102rexaminedindimethylformamideRanddiluteto100.0mLwith[344423-98-9]thesamesolvent.DEFINITIONTestsolution(b).Dissolve50mgofthesubstancetobeCalcium(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-examinedindimethylformamideRanddiluteto50.0mLwith4-(phenylcarbamo

5、yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoatethesamesolvent.trihydrate.Referencesolution(a).Dissolve40.0mgofatorvastatinContent:97.0percentto102.0percent(anhydroussubstance).calciumtrihydrateCRSindimethylformamideRanddiluteto100.0mLwiththesamesolvent.CHARACTERSReferencesolution(b).Dilute1.0mLoftestsol

6、ution(b)toAppearance:whiteoralmostwhitepowder.100.0mLwithdimethylformamideR.Dilute1.0mLofthisSolubility:veryslightlysolubleinwater,slightlysolublesolutionto10.0mLwithdimethylformamideR.inethanol(96percent),practicallyinsolubleinmethyleneReferencesolution(c).Dissolve2.5mgofatorvastatinchloride.impuri

7、tyACRS,2.5mgofatorvastatinimpurityBCRS,Itshowspolymorphism(5.9).2.5mgofatorvastatinimpurityCCRS,2.5mgofatorvastatinimpurityDCRSand2.5mgofthesubstancetobeexaminedIDENTIFICATIONindimethylformamideRanddi