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1、dentificationofForcedDegradationProductsofItopridebyLC-PDAandLC-MSAbstractDegradationproductsofitoprideformedunderdifferentforcedconditionshavebeenidentifiedusingLC・PDAandLC-MStechniques.Itopridewassubjectedtoforceddegradationundertheconditionsofhydrolysi
2、s,photolysis,oxidation,dryandwetheat,inaccordancewiththeInternationalConferenceonHarmonization.ThestresssolutionswerechromatographedonreversedphaseC18(250x4.6mm,5
3、im)columnwithamobilephasemethanokwater(55:45,v/v)atadetectionwavelengthof215nm.Itopridedegra
4、dedinacid,alkaliandoxidativestressconditions.Thestabilityindicatingmethodwasdevelopedandvalidate止ThedegradationpathwayofthedrugtoproductsII-VIIIisproposed.Keywords:Degradationproducts,forceddegradation,itopride,stabilityindicating,validationItopridehydroc
5、hlorideisanovel,synthesized,gastroprokineticdrug,whichstimulatesgastrointestinalmotoractivitythroughthesynergisticeffectsofdopamineD2-receptorblockadeandacetylcholineesteraseinhibitors[1-3].Chemically,itisN-[p-2(2-(dimethylamino)ethoxy)-benzyl]veratramide
6、hydrochloride.Benzamidestructure,amideandetherlinkagesinthedrugmoleculemakeitsusceptibletodegradation.Duetolabilityoftheselinkagesandfunctionalgroupstohydrolysisandoxidation,severaldegradationproductswereanticipatedtobeformedduringstabilitytestingofthedru
7、g[4].Itoprideisnotofficialinanypharmacopoeia.Fewanalyticalmethodshavebeenreportedforthequantitativeestimationofitopride.MushirodaetaI.[5]havereportedHPLCmethodwithfluorescencedetection.Thelimitationofthismethodwastheuseofahighratioofbuffersolutioninthemob
8、ilephasethatcancausedamagetothereversephasecolumn.TakaharaetaI.[6]havereportedHPLCmethodforthesimultaneousdeterminationofitoprideand让smetabolitesinhumanserumandurineusingautomatedcolumnswitching.TwosensitiveandreproducibleHPLCandHPTLCmethodshavebeendescri
9、bedforthequantitativedeterminationofitopridehydrochlorideinthepresenceofitsdegradationproducts[7].HPTLCmethodforthedeterminationofitopridehydrochlorideinpharmaceuticalpreparationandbulkdrughasbeenreported[8].However