盐酸文拉法辛缓释胶囊-USP标准

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1、undefinedUSPMonographs:VenlafaxineHydrochlorideExtended-Release...页码，1/8Addthefollowing:VenlafaxineHydrochlorideExtended-ReleaseCapsulesDEFINITIONVenlafaxineHydrochlorideExtended-ReleaseCapsulescontainanamountofVenlafaxineHydrochlorideequivalenttoNLT90.0%andNMT110.0%ofthelabele

2、damountofvenlafaxine(CHNO).17272IDENTIFICATION•A.ULTRAVIOLETABSORPTION197UWavelengthrange:250–310nm•B.TheretentiontimeofthemajorpeakoftheSamplesolutioncorrespondstothatoftheStandardsolution,asobtainedintheAssay.ASSAY•PROCEDUREMobilephase:Acetonitrile,triethylamine,andwater(250:

3、4:750).AdjustwithphosphoricacidtoapHof3.5.Standardsolution:0.25mg/mLofUSPVenlafaxineHydrochlorideRSinMobilephaseSamplestocksolution:Nominally1.0mg/mLofvenlafaxine(fromthecontentsofNLT10Capsules)preparedasfollows.TransferaweighedquantityofCapsulecontentstoasuitablevolumetricflas

4、k.Add8%oftheflaskvolumeofacetonitrile,andshakefor40min.Add50%offlaskvolumeofMobilephase,andshakeforanadditional20min.DilutewithMobilephasetovolume.Passaportionthroughasuitablefilterof0.45-µmporesize.Samplesolution:0.25mg/mLofvenlafaxine(usingthefiltratefromtheSamplestocksolutio

5、n)inMobilephaseChromatographicsystem(SeeChromatography621,SystemSuitability.)Mode:LCDetector:UV226nmColumn:4.6-mm×25-cm;5-µmpackingL1Flowrate:1mL/minInjectionvolume:10µLRuntime:1.5timestheretentiontimeofvenlafaxineSystemsuitabilitySample:StandardsolutionSuitabilityrequirementsT

6、ailingfactor:NMT2.0http://192.168.50.160/usp35s2/uspnf/pub/data/v35302/usp35nf30s2_m8...2012-10-30undefinedUSPMonographs:VenlafaxineHydrochlorideExtended-Release...页码，2/8Relativestandarddeviation:NMT1.5%AnalysisSamples:StandardsolutionandSamplesolutionCalculatethepercentageofth

7、elabeledamountofvenlafaxine(CHNO)in17272theportionofCapsulestaken:Result=(rU/rS)×(CS/CU)×(Mr1/Mr2)×100rU=peakresponseoftheSamplesolutionrS=peakresponseoftheStandardsolutionCS=concentrationofUSPVenlafaxineHydrochlorideRSintheStandardsolution(mg/mL)CU=nominalconcentrationofvenlaf

8、axineintheSamplesolution(mg/mL)Mr1=molecularweightofve