阿托伐他汀钙欧洲药典7[1].1

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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-ca

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

3、rityE=about0.8.Systemsuitability:referencesolution(a):—resolution:minimum2.0betweenthepeaksduetoimpurityEandatorvastatin.Limit:—impurityE:notmorethantheareaoftheprincipalpeakinthechromatogramobtainedwithreferencesolution(b)(0.3percent).Relatedsubstances.Liquidchromatography(2.2.29).Testsol

4、ution(a).Dissolve40.0mgofthesubstancetobeCHCaFNO,3HOM1209666824102rexaminedindimethylformamideRanddiluteto100.0mLwith[344423-98-9]thesamesolvent.DEFINITIONTestsolution(b).Dissolve50mgofthesubstancetobeCalcium(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-examinedindimethylformami

5、deRanddiluteto50.0mLwith4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoatethesamesolvent.trihydrate.Referencesolution(a).Dissolve40.0mgofatorvastatinContent:97.0percentto102.0percent(anhydroussubstance).calciumtrihydrateCRSindimethylformamideRanddiluteto100.0mLwiththesamesolvent.C

6、HARACTERSReferencesolution(b).Dilute1.0mLoftestsolution(b)toAppearance:whiteoralmostwhitepowder.100.0mLwithdimethylformamideR.Dilute1.0mLofthisSolubility:veryslightlysolubleinwater,slightlysolublesolutionto10.0mLwithdimethylformamideR.inethanol(96percent),practicallyinsolubleinmethyleneRef

7、erencesolution(c).Dissolve2.5mgofatorvastatinchloride.impurityACRS,2.5mgofatorvastatinimpurityBCRS,Itshowspolymorphism(5.9).2.5mgofatorvastatinimpurityCCRS,2.5mgofatorvastatinimpurityDCRSand2.5mgofthesubstancetobeexaminedIDENTIFICATIONindimethylformamideRanddi