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1、美国药典：ClonidineHydrochlorideC9H9Cl2N3·HCl266.55Benzenamine,2,6-dichloro-N-2-imidazolidinylidene-,monohydrochloride.2-[(2,6-Dichlorophenyl)imino]imidazolidinemonohydrochloride[4205-91-8].»ClonidineHydrochloridecontainsnotlessthan98.5percentandnotmorethan1
2、01.0percentofC9H9Cl2N3·HCl,calculatedonthedriedbasis.Packagingandstorage—Preserveintightcontainers.Storeat25,excursionspermittedbetween15and30.USPReferencestandards11—USPClonidineHydrochlorideRS.Identification—A:InfraredAbsorption197K.B:UltravioletAbsor
3、ption197U—Solution:330µgpermL.Medium:0.01Nhydrochloricacid.Absorptivitiesat272nm,calculatedonthedriedbasis,donotdifferbymorethan3.0%.C:ItrespondstothetestsforChloride191.pH791:between3.5and5.5,inasolution(1in20).Lossondrying731—Dryitat105toconstantweigh
4、t:itlosesnotmorethan0.5%ofitsweight.Residueonignition281:notmorethan0.1%.Chromatographicpurity—Dissolve200mginmethanol,anddilutewithmethanolto2.0mLtoobtainthetestsolution.DissolveasuitablequantityofUSPClonidineHydrochlorideRSinmethanoltoobtainaStandards
5、olutionhavingaknownconcentrationof100mgpermL.DiluteaportionofthissolutionquantitativelyandstepwisewithmethanoltoobtainadilutedStandardsolutionhavingaconcentrationof100µgpermL.Applyseparate2-µLportionsofthetestsolution,theStandardsolution,andthedilutedSt
6、andardsolutiontoasuitablethin-layerchromatographicplate(seeChromatography621)coatedwitha0.25-mmlayerofchromatographicsilicagelmixture.Developthechromatograminafreshlypreparedsolventsystemconsistingofamixtureoftoluene,dioxane,dehydratedalcohol,andammoniu
7、mhydroxide(10:8:2:1),untilthesolventfronthasmovedthree-fourthsofthelengthoftheplate.Removetheplatefromthechamber,allowthesolventtoevaporate,anddryitat100for1hour.Diptheplateintoadippingchamberfilledtothree-fourthsofitsheightwithsodiumhypochloritesolutio
8、n,dilutedtocontain0.5%availablechlorine,dryinafumehoodwithacurrentofairfor1hour,andspraywithstarch-potassiumiodideTS:theRFvalueoftheprincipalspotfromthetestsolutioncorrespondstothatoftheStandardsolution.Anyotherspotobtainedfromth
