Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development PDF
Preview Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development
SEPARATION SCIENCE AND TECHNOLOGY VOLUME 14 Areference series edited by SATINDER AHUJA This page intentionally left blank PRACTICAL APPLICATION OF SUPERCRITICAL FLUID CHROMATOGRAPHY FOR PHARMACEUTICAL RESEARCH AND DEVELOPMENT VOLUME 14 Edited by M H ICHAEL ICKS AnalyticalResearch&Development,MerckResearchLabs,Rahway,NJ,UnitedStates P F AUL ERGUSON NewModalities&ParenteralDevelopment,PharmaceuticalTechnology&Development,Operations, AstraZeneca,Macclesfield,UnitedKingdom AcademicPressisanimprintofElsevier 125LondonWall,LondonEC2Y5AS,UnitedKingdom 525BStreet,Suite1650,SanDiego,CA92101,UnitedStates 50HampshireStreet,5thFloor,Cambridge,MA02139,UnitedStates TheBoulevard,LangfordLane,Kidlington,OxfordOX51GB,UnitedKingdom Copyright©2022ElsevierInc.Allrightsreserved. Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicor mechanical,includingphotocopying,recording,oranyinformationstorageandretrievalsystem,without permissioninwritingfromthepublisher.Detailsonhowtoseekpermission,furtherinformationaboutthe Publisher’spermissionspoliciesandourarrangementswithorganizationssuchastheCopyrightClearance CenterandtheCopyrightLicensingAgency,canbefoundatourwebsite:www.elsevier.com/permissions. ThisbookandtheindividualcontributionscontainedinitareprotectedundercopyrightbythePublisher(other thanasmaybenotedherein). Notices Knowledgeandbestpracticeinthisfieldareconstantlychanging.Asnewresearchandexperiencebroadenour understanding,changesinresearchmethods,professionalpractices,ormedicaltreatmentmaybecomenecessary. Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgeinevaluatingandusing anyinformation,methods,compounds,orexperimentsdescribedherein.Inusingsuchinformationormethods theyshouldbemindfuloftheirownsafetyandthesafetyofothers,includingpartiesforwhomtheyhavea professionalresponsibility. Tothefullestextentofthelaw,neitherthePublishernortheauthors,contributors,oreditors,assumeanyliability foranyinjuryand/ordamagetopersonsorpropertyasamatterofproductsliability,negligenceorotherwise,orfrom anyuseoroperationofanymethods,products,instructions,orideascontainedinthematerialherein. ISBN:978-0-323-88487-7 ISSN:1877-1718 ForinformationonallAcademicPresspublications visitourwebsiteathttps://www.elsevier.com/books-and-journals Publisher:SusanDennis AcquisitionsEditor:CharlotteRowley EditorialProjectManager:ZsereenaRoseMampusti ProductionProjectManager:SruthiSatheesh CoverDesigner:VickyPearsonEsser TypesetbySTRAIVE,India Dedication Forthe twoconstants inmylife, Isobel andEmily,withoutwho’s patience and support thisbook would not have been possible Paul Ferguson, November 2022 Formyfamily,Thomas,Brendan,Georgina,andKathy,forinspiringmeandformycolleaguesfor sharing this journeywith me MichaelHicks, November 2022 This page intentionally left blank Contents Contributors xi Otheroperatingparameters:Temperature,pressure andflowrate 64 Preface xiii Predictingretentionandselectivity 65 Summary 66 1. Evolution of packed column SFC References 66 as a greener analytical tool for pharmaceutical analysis 4. Measurements of drugs and metabolites in biological matrices using SFC SusanOlesikandRaffealBennett and SFE-SFC-MS Discoveryofsupercriticalfluidsanditsrelevanceto BradyW.Drennan,A.PaigeWicker,BlairK.Berger, analyticalseparationscience 1 andKevinA.Schug Sustainableaspectsofsubcriticalandsupercritical chromatographicseparationmethods 9 Introductiontodrugandmetaboliteanalysis AnalyticalscalesubcriticalSFC 10 inbiologicalmatricesusingSFCand Analyticalenhanced-fluidityliquid SFE-SFC-MS 73 chromatography 12 On-lineSFE-SFC-MSmethoddevelopmentfor Preparativeandanalyticalscaleinstrument biologicalmatrices 75 improvements 13 Drugmetabolismandpharmacokinetics(DMPK) Currentutilityandrecentadvancements 20 monitoringindiscoveryanddevelopment 88 Futuredirections 22 Discoveryanddereplicationofnaturalproducts 93 References 22 Conclusions 94 References 94 2. Application space for SFC in 5. Synthetic chemistry screening for robust pharmaceutical drug discovery analysis and purification from discovery and development through to development GioacchinoLucaLosacco,AmandineDispas,Jean-LucVeuthey, TimUnderwood,SeanHindley,AndyKnaggs,andCraigWhite andDavyGuillarme Introduction 101 Introduction 29 Screeningstrategies 103 Discussion 33 Practicality 119 ConsiderationsonSFCasananalyticaltoolindrug Aspectsforconsideration 123 discoveryanddevelopment 38 Futurerefinements 128 Conclusionsandperspectives 42 References 129 References 43 6. Application of preparative SFC in the 3. Selection of SFC stationary pharmaceutical industry and mobile phases JenniferKingston,HannaLeek,AstridBuica,KristinaO€hl(cid:2)en, CarolineWestandEricLesellier KatieProctor,JoannaRaubo,MatthewSanders,andLindaThunberg Introduction 49 IntroductiontotheuseofpreparativeSFC 133 CurrentstationaryphasechemistriesforSFC 49 PreparativeSFCinstrumentationand Flexiblemobilephasecomposition 59 infrastructure 134 vii viii Contents FeaturesandcontrolsduringpreparativeSFC 138 RoleofwaterinmodernSFC 261 Temperaturecontrol 143 Enhanced-fluidityliquidchromatography 269 Detectionsystems 143 ApplicationsofSFCtobiomolecules 279 Fractioncollection 144 Concludingremarks 290 MethoddevelopmentinpreparativeSFC 145 References 290 PreparativeSFCapplications:Casestudieswithin AstraZenecaresearchlaboratories 148 10. Different detectors used with SFC SFCasasustainablechromatographictechnique 159 G.JohnLangley,SergioCancho-Gonzalez, Conclusions 163 andJulieM.Herniman References 163 Introductiontodetectorsusedwith 7. Method development approaches modernSFC 299 for small-molecule analytes GenericdetectorsusedwithSFC 300 CouplingSFCtomassspectrometric SyameKhater,PaulFerguson, detectors 313 andAlexandreGrand-Guillaume-Perrenoud Conclusions 321 Introduction 167 Acknowledgment 321 Methoddevelopment“prework” 170 References 321 ScreeningtoolutilizationtoidentifyoptimalSFC parameters 174 11. SFC in GMP testing and quality Methodvalidation 205 control of medicinal drug products Continuousmethodperformanceverification 210 Summary 211 AdrianClarke,PaulFerguson,andMichaelHicks Acknowledgments 212 Introduction 325 References 212 CurrentuseofSFCinpharmaceutical development 327 8. Application of SFC for the TransferofmethodstomanufacturingQC characterization of formulated facilities 332 drug products Futurerequirementstowardregulatoryacceptanceof SFCmethods 344 PaulFerguson,RebeccaCross,andGesaSchad Conclusions 348 Introduction 221 Acknowledgments 348 Drugformulations 222 References 348 Samplepreparationprocedures 225 Waterandorganicsolventsassamplediluentsin 12. Best practices and instrumental SFCforAPIsandsolid-oraldosageforms 230 troubleshooting for successful AlternativeapproachestosolubilizeanalytesinSFC SFC methods compatiblesolvents 237 Characterizationofpolymerexcipients 241 FionaBell,PaulFerguson,RebeccaPoulten,EmilyRoddy, andWilliamFarrell Conclusions 246 Acknowledgments 247 Introduction 353 Appendix:Constituentsofformulateddrugsdiscussed Systemconfiguration 354 inchapter 247 Bestpracticeforsystemsetup 356 References 252 Systemperformancechecks 357 Cylinderissues 361 9. Expanding the boundaries of SFC: Instrumenttroubleshootinganderrors 364 Analysis of biomolecules Eluenteffects 369 Chromatographictroubleshooting 371 MartinBeres Optimizationofdetectorsensitivity 374 Historicalproblemsanalyzingpolarmoleculesvia Conclusions 374 SFC 257 References 375 ix Contents 13. The state-of-the-art and future Methoddevelopment,performanceandprediction perspectives for SFC aspects 386 Methodscaling 390 PaulFergusonandMichaelHicks FuturedirectionsandapplicationsofSFC 392 Sustainableinstrumentdesign 394 Introduction 377 Conclusions 397 Reflectiononpreviouschapters 378 Acknowledgments 398 TheoreticalperformanceofSFC 382 References 398 Influenceofnewcolumnparticletechnologiesand instrumentdesignonSFCperformance 383 List of abbreviations 403 Considerationsforfutureinstrumentapplicationand design 384 Index 409
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