埃索美拉唑镁usp34标准

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1、２０１０　ＵＳＰＣ　Ｏｆｆｉｃｉａｌ　５／１／１１　－　７／３１／１１　ＵＳＰ　Ｍｏｎｏｇｒａｐｈｓ：　Ｅｓｏｍｅｐｒａｚｏｌｅ　．．．页码，１／７EsomeprazoleMagnesiumesohmeprazolemagneezeeum.C34H36MgN6O6S2·3H2OTrihydrate:767.17C34H36MgN6O6S2Anhydrous:713.121H-Benzimidazole5-methoxy-2-S-4-methoxy-35-dimethyl-2-pyridinylmethylsulfinylmagnesiumsalt2:1trihydra

2、te5-Methoxy-2-S-4-methoxy-35-dimethyl-2-pyridylmethylsulfinylbenzimidazolemagnesiumsalt2:1trihydrate217087-09-7.DEFINITIONEsomeprazoleMagnesiumcontainsNLT98.0andNMT102.0ofC34H36MgN6O6S2calculatedontheanhydrousbasis.IDENTIFICATIONA.INFRAREDABSORPTION197KB.TheSamplesolutionpreparedandtest

3、edasdirectedinthetestforContentofMagnesiumexhibitsasignificantabsorptionat285.2nm.ASSAYPROCEDURESolutionA:Dissolve0.725gofmonobasicsodiumphosphateand4.472gofanhydrousdibasicsodiumphosphatein300mLofwateranddilutewithwaterto1000mL.Dilute250mLofthissolutionwithwaterto1000mL.Ifnecessaryadju

4、stwithphosphoricacidtoapHof7.6.SolutionB:Mix11mLof0.25Mtribasicsodiumphosphatewith22mLof0.5Mdibasicsodiumphosphateanddilutewithwaterto100mL.Mobilephase:AcetonitrileandSolutionA7:13Standardsolution:Transfer10mgofUSPOmeprazoleRStoa200-mLvolumetricflaskanddissolveinabout10mLofmethanol.Add1

5、0mLofSolutionBanddilutewithwatertovolume.NOTE—Thissolutioncontains0.05mg/mLofomeprazole.Samplesolution:Transfer10mgofEsomeprazoleMagnesiumtoa200-mLvolumetricflaskanddissolveinabout10mLofmethanol.Add10mLofSolutionBｆｉｌｅ：／／Ｃ：＼ｃｏｍ＿ｃａｉｓｌａｂｓ＿ｅｂｋ＼ｄａｔａ＼ｖ３４２９０＼ｕｓｐ３４ｎｆ２９ｓ０＿ｍ３０５８８．ｈｔｍｌ２０１１－５－４２０１０

6、　ＵＳＰＣ　Ｏｆｆｉｃｉａｌ　５／１／１１　－　７／３１／１１　ＵＳＰ　Ｍｏｎｏｇｒａｐｈｓ：　Ｅｓｏｍｅｐｒａｚｏｌｅ　．．．页码，２／７anddilutewithwatertovolume.NOTE—Thissolutioncontains0.05mg/mLofesomeprazolemagnesium.ChromatographicsystemSeeChromatography621SystemSuitability.Mode:LCDetector:UV280nmColumn:4.0-mm×12.5-cmora4.6-mm×15-cm5-mpackingL7.N

7、OTE—Alternativelya3.9-mm×15-cmcolumnthatcontains4-mpackingL1maybeused.Flowrate:1mL/minInjectionsize:20LSystemsuitabilitySample:StandardsolutionSuitabilityrequirementsColumnefficiency:NLT2000theoreticalplatesRelativestandarddeviation:NMT2.0AnalysisSamples:StandardsolutionandSamp