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1、USP34OfficialMonographs/Atorvastatin1949AtorvastatinCalcium.3H2OC66H68CaF2N40io-3HQ1209.42C66H68CQF2N4O101155.341H-Pyrrole-1-heptanoicacid,2-(4-fluorophenyl)-p,8-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylami-no)carbonyl]-,calciumsalt(2:1),trihydrate[H・(F,F)卜;Calcium
2、(卩/?,8F?)-2-(p-fluorophenyl)・
3、3,6-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1・heptanoate(1:2),trihy-drate[344423-98-9].Anhydrous[134523-03-8].DEFINITIONAtorvastatinCalciumcontainsNLT98.0%andNMT102.0%ofCesHesCaFaN^io,calculatedontheanhydrousbasis.IDENTIFIC
4、ATION•A.InfraredAbsorption(197K)•B.CalciumDiluent:Methanol,water,andhydrochloricacid(75:25:2)Blank:DiluentSamplesolution:0.05mg/mLofAtorvastatinCalciuminDiluentAnalysisSamples:SamplesolutionandBlankSpectrometricconditions(seeChromatography(621))—The(SeeSpectrophotometrya
5、ndLight-Scattering(851>.)Mode:AtomicabsorptionspectrophotometryAnalyticalwavelength:Calciumemissionlineat422.7nmFlame:Air-acetyleneAcceptaneecriteria:TheSamplesolutionexhibitsasignificantabsorptionatthecalciumemissionlineat422.7nm.ASSAYPROCEDUREBuffer:3.9g/Lofammoniumace
6、tateinwater.AdjustwithglacialaceticacidtoapHof5.0±0.1・SolutionA:Acetonitrile,stabilizer-freetetrahydrofuran,andBuffer(21:12:67)SolutionB:Acetonitrile,stabilizer-freetetrahydrofuran,andBuffer(61:12:27)Diluent:A/,A/-dimethylformamideMobilephase:Seethegradienttablebelow・[No
7、te—Ifnecessary,adjusttheMobilephasebyincreasingordecreasingthepercentageofacetonitrileorthepHoftheammoniumacetatesolutiontoachievearetentiontimeof26-34minfortheatorvastatinpeak.]Time(min)SolutionA(%)SolutionB(%)01000401000702080850100100010010510001151000Systemsuitabilit
8、ysolution:0.05mg/mLofUSPAtorvastatinCalciumRSand0.06mg/mLofUSPAtorvastatinRelatedCompoundBRSinDiluentStandardsolution:0.4mg/mLofUSPAtorvastatinCalciumRS泊Diluent.[Note—Usesonicationifnecessary]Samplesolution:0.4mg/mLofAtorvastatinCalciumin£?/7i/ent[N0TE—Usesonicationifnec
9、essary.)Chromatographicsystem(SeeChromatography(621>,SystemSuitability.)[NOTE—Ifsignificantfrontingofth
