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CilostazolTablets

CilostazolTabletscontainnotlessthan90.0percentandnotmorethan110.0
percentofthelabeledamountofcilostazol(C20H27N5O2).
PackagingandstoragePreserveintightandlightresistantcontainers.Storeatcontrolledroom
temperature.

USPReferencestandards 11
USPCilostazolRS .

Identification

A:InfraredAbsorption 197S

StandardsolutionPrepareasolutionofUSPCilostazolRSinchloroformhavingaknownconcentration
of100mgpermL.

TestsolutionAccuratelytransferaquantityoffinelypowderedTablets,equivalenttoabout100mgof
cilostazol,intoaglasscontainer.Add1mLofchloroform,shakefor1minute,andfilterthrougha0.5mor
finerfilter.

B:TheretentiontimeofthecilostazolpeakinthechromatogramoftheAssaypreparationcorrespondsto
thatinthechromatogramoftheStandardpreparation,asobtainedintheAssay.

Uniformityofdosageunits 905 :meettherequirements.

Assay

MobilephasePrepareafilteredanddegassedmixtureofwater,acetonitrile,andmethanol(10:7:3).Make
adjustmentsifnecessary(seeSystemSuitabilityunderChromatography 621 ).

InternalstandardsolutionPrepareasolutionofbenzophenoneinmethanolhavingaknownconcentration
of4mgpermL.

StandardpreparationDissolveanaccuratelyweighedquantityofUSPCilostazolRSandanappropriate
amountofInternalstandardsolutionanddilutequantitatively,andstepwiseifnecessary,withmethanolto
obtainasolutionhavingaknownconcentrationofabout0.1mgofUSPCilostazolRSand0.04mgofthe
internalstandardpermL.

AssaypreparationWeighandfinelypowdernotfewerthan20Tablets.Transferanaccuratelyweighed
portionofthepowder,equivalenttoabout50mgofcilostazol,toasuitablevolumetricflaskandaddan
appropriatequantityofInternalstandardsolution.Dilutequantitatively,andstepwiseifnecessary,with
methanoltoobtainasolutionhavingaknownconcentrationofabout0.1mgofUSPCilostazolRSand0.04
mgoftheinternalstandardpermL.Passaportionofthissolutionthroughamembranefilterhavinga0.5
morfinerporosity,andusethefiltrate.

Chromatographicsystem(seeChromatography 621 )Theliquidchromatographisequippedwitha

254nmdetectoranda4.6mm150cmcolumnthatcontainspackingL1.Theflowrateisabout1mLper
minute.Thecolumntemperatureismaintainedatambienttemperature.ChromatographtheStandard
preparation,andrecordthepeakresponsesasdirectedforProcedure:theresolution,R,betweenthe
cilostazolandbenzophenonepeakselutedinthisorderisnotlessthan9.0andtherelativestandard
deviationforreplicateinjectionsisnotmorethan1.5%.

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ProcedureSeparatelyinjectequalvolumes(about10L)oftheStandardpreparationandtheAssay
preparationintothechromatograph,recordthechromatograms,andmeasuretheareasforthemajor
peaks.CalculatethepercentageofthelabeledamountofC20H27N5O2intheportionofTabletstakenby
theformula:
100(CS/CU)(rU/rS)

inwhichCSistheconcentration,inmgpermL,ofUSPCilostazolRSintheStandardpreparationCUisthe
concentrationofcilostazolintheAssaypreparation,basedonthelabeledquantityperTabletandtheextent
ofdilutionandrUandrSarethepeakresponsesofcilostazolobtainedfromtheAssaypreparationandthe
Standardpreparation,respectively.

AuxiliaryInformationPleasecheckforyourquestionintheFAQsbeforecontactingUSP.
Topic/Question Contact ExpertCommittee
Monograph SujathaRamakrishna,Ph.D. (MDCV05)MonographDevelopment
Scientist Cardiovascular
13018168349
Reference LiliWang,TechnicalServices
Standards Scientist
13018168129
RSTech@usp.org
USP32NF27Page1934
PharmacopeialForum:VolumeNo.33(3)Page395
ChromatographicColumn

CILOSTAZOLTABLETS

Chromatographiccolumnstextisnotderivedfrom,andnotpartof,USP32orNF27.

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