Stability-indicating assay method for determination of actarit,its process related impurities and degradation productsInsight into stability profile and degradation pathways.pdfVIP

Determinationofactarit，impuritiesanddegradationproductsbyHPLC-PDA-MS 375 Several high performance liquid chromatography fHPLC) mehtodwasdevelopedofrsimultaneousdeterminationofactarit， methodshavebeenreported in theliteratureforna alysisofthe itsprocessrelatedimpuritiesna ddegradation products．Rateof drugactarit；however，hteyaremainlyrelatedtoitsdetermination degradationofthedrugwasdeterminedbyperforminghyrdolysis inbiological fluids 7『—91．Estimationofactaritinpharmaceutical ofhtedrugatdifferenttemperatureconditions． fomrulationbyHPLCwasalsoreported 1『01nadhtedegradation ofactaritin alkaline and acidic solutionswasevaluated．The 2． Experimental overallchemical stabi1itvofactaritwasnotsufficientlyaddressed andthismehtodcna notbeconsideredasamethodofrindicating 2．． Reagentsandchemicals stability．Ph0tObiOl0gicalpropertiesofinvitrophototoxicological assaysandphotodegradationproductsofactaritwerestudied 『11]． The chemicalstability ofactaritwiht respectto other stress Th edrugactarit，itsprocessrelatedimpurities(IMP)anddegrada— conditions(oxidation，therma1)ispresentlyunknown．Anexhaus． tionproducts(DP)weresynhtesizedinhtelab．Buffersaltsand rivestudyon thestabilityofactaritisdemandingashtecurrent glacial acetic acid were purchased rfom M erck，India．Highly International Conference on Harmonisation (icH guidelines purifiedwaterofrHPLC wasobtainedfrom MilliO pluswater requirehtatstabilityna alysisshouldbedoneby usingstabi1itv— purifyingsystem．M illipore．M ehtnaolnad acetonitrileofHPLC indicatingassaymethods(SIAM)．Afterstresstestingonthedurg gradewereobtainedrfom FischerScientific，India．Mobilephase undervariousconditions，includinghydrolysis(atvariouspH)， wasvacuum filtered htrough a0．22um poly．tetrafluoroethylene oxidati