{"id":"https://openalex.org/W7225560215","doi":"https://doi.org/10.22159/ijap.2026v18i6.59307","title":"Design Space\u2013Guided Chiral Chromatographic Method Development for Enantiomeric Resolution and Purity Assessment Thereby Monitoring the Active S-Isomer of Pirtobrutinib by LC-MS/MS","display_name":"Design Space\u2013Guided Chiral Chromatographic Method Development for Enantiomeric Resolution and Purity Assessment Thereby Monitoring the Active S-Isomer of Pirtobrutinib by LC-MS/MS","publication_year":2026,"publication_date":"2026-11-07","ids":{"openalex":"https://openalex.org/W7225560215","doi":"https://doi.org/10.22159/ijap.2026v18i6.59307"},"language":"en","primary_location":{"id":"doi:10.22159/ijap.2026v18i6.59307","doi":"https://doi.org/10.22159/ijap.2026v18i6.59307","is_oa":true,"landing_page_url":"https://doi.org/10.22159/ijap.2026v18i6.59307","pdf_url":"https://journals.innovareacademics.in/index.php/ijap/article/download/59307/34565","source":{"id":"https://openalex.org/S2764477652","display_name":"International Journal of Applied Pharmaceutics","issn_l":"0975-7058","issn":["0975-7058"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":["poland-100","russia-white-list-3"],"host_organization":"https://openalex.org/P4322697801","host_organization_name":"Innovare Academic Sciences","host_organization_lineage":["https://openalex.org/P4322697801"],"host_organization_lineage_names":["Innovare Academic Sciences"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Applied Pharmaceutics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://journals.innovareacademics.in/index.php/ijap/article/download/59307/34565","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5153442478","display_name":"Akunuri Ujwala","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405266258","display_name":"Chaitanya","ror":"https://ror.org/01m1bpg27","country_code":"IN","type":"education","lineage":["https://openalex.org/I4405266258"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"AKUNURI UJWALA","raw_affiliation_strings":["Department of Pharmacy, Chaitanya (Deemed to be University), Gandipet, Himayath Nagar (Vill), Hyderabad-500075, Telangana, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy, Chaitanya (Deemed to be University), Gandipet, Himayath Nagar (Vill), Hyderabad-500075, Telangana, India","institution_ids":["https://openalex.org/I4405266258"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161294311","display_name":"KUMARASWAMY GANDLA","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405266258","display_name":"Chaitanya","ror":"https://ror.org/01m1bpg27","country_code":"IN","type":"education","lineage":["https://openalex.org/I4405266258"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"KUMARASWAMY GANDLA","raw_affiliation_strings":["Department of Pharmacy, Chaitanya (Deemed to be University), Gandipet, Himayath Nagar (Vill), Hyderabad-500075, Telangana, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy, Chaitanya (Deemed to be University), Gandipet, Himayath Nagar (Vill), Hyderabad-500075, Telangana, India","institution_ids":["https://openalex.org/I4405266258"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5161272925","display_name":"DANDU VENKATA SAI PRAMEELA","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"DANDU VENKATA SAI PRAMEELA","raw_affiliation_strings":["Scientific Liaison Officer, YMC INDIA Pvt Ltd., Gajularamaaram, Hyderabad-500014,  India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Scientific Liaison Officer, YMC INDIA Pvt Ltd., Gajularamaaram, Hyderabad-500014,  India","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"393","last_page":"403"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10908","display_name":"Analytical Chemistry and Chromatography","score":0.9916999936103821,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T10908","display_name":"Analytical Chemistry and Chromatography","score":0.9916999936103821,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.007600000128149986,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10013","display_name":"Asymmetric Synthesis and Catalysis","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/1605","display_name":"Organic Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/pirtobrutinib","display_name":"pirtobrutinib","score":0.9750000238418579},{"id":"https://openalex.org/keywords/enantiomeric-resolution","display_name":"enantiomer resolution","score":0.7910000085830688},{"id":"https://openalex.org/keywords/chiral-chromatography","display_name":"chiral chromatography","score":0.8199999928474426},{"id":"https://openalex.org/keywords/bruton-tyrosine-kinase-inhibitors","display_name":"BTK inhibitors","score":0.8619999885559082},{"id":"https://openalex.org/keywords/quality-by-design","display_name":"quality by design","score":0.7979999780654907},{"id":"https://openalex.org/keywords/full-factorial-design","display_name":"full factorial design","score":0.734000027179718},{"id":"https://openalex.org/keywords/normal-phase-hplc","display_name":"normal-phase HPLC","score":0.6620000004768372},{"id":"https://openalex.org/keywords/lc-ms-ms-quantification","display_name":"LC-MS/MS quantification","score":0.8240000009536743},{"id":"https://openalex.org/keywords/tablet-assay","display_name":"tablet assay","score":0.49900001287460327},{"id":"https://openalex.org/keywords/impurity-profiling","display_name":"impurity profiling","score":0.6449999809265137},{"id":"https://openalex.org/keywords/racemization","display_name":"racemization","score":0.5709999799728394},{"id":"https://openalex.org/keywords/stereoselective-synthesis","display_name":"stereoselective synthesis","score":0.7979999780654907},{"id":"https://openalex.org/keywords/pharmaceutical-quality-control","display_name":"pharmaceutical quality control","score":0.6060000061988831}],"concepts":[{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.7858999967575073},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.7379000186920166},{"id":"https://openalex.org/C138268822","wikidata":"https://www.wikidata.org/wiki/Q1051925","display_name":"Resolution (logic)","level":2,"score":0.6902999877929688},{"id":"https://openalex.org/C2777463227","wikidata":"https://www.wikidata.org/wiki/Q408047","display_name":"Acetonitrile","level":2,"score":0.6643000245094299},{"id":"https://openalex.org/C486523","wikidata":"https://www.wikidata.org/wiki/Q494483","display_name":"Enantiomer","level":2,"score":0.6534000039100647},{"id":"https://openalex.org/C2777449572","wikidata":"https://www.wikidata.org/wiki/Q414196","display_name":"Diethylamine","level":2,"score":0.6359999775886536},{"id":"https://openalex.org/C119128265","wikidata":"https://www.wikidata.org/wiki/Q900165","display_name":"Detection limit","level":2,"score":0.6172000169754028},{"id":"https://openalex.org/C169222746","wikidata":"https://www.wikidata.org/wiki/Q4116558","display_name":"Factorial experiment","level":2,"score":0.46459999680519104},{"id":"https://openalex.org/C3141732","wikidata":"https://www.wikidata.org/wiki/Q568761","display_name":"Enantiomeric excess","level":4,"score":0.4546000063419342},{"id":"https://openalex.org/C60002323","wikidata":"https://www.wikidata.org/wiki/Q25819","display_name":"Racemization","level":2,"score":0.42309999465942383},{"id":"https://openalex.org/C71987851","wikidata":"https://www.wikidata.org/wiki/Q7216430","display_name":"Impurity","level":2,"score":0.40139999985694885},{"id":"https://openalex.org/C77170095","wikidata":"https://www.wikidata.org/wiki/Q1753188","display_name":"Linearity","level":2,"score":0.39469999074935913},{"id":"https://openalex.org/C113196181","wikidata":"https://www.wikidata.org/wiki/Q485223","display_name":"Analytical Chemistry (journal)","level":2,"score":0.3869999945163727},{"id":"https://openalex.org/C202799725","wikidata":"https://www.wikidata.org/wiki/Q272035","display_name":"Accuracy and precision","level":2,"score":0.3788999915122986},{"id":"https://openalex.org/C172120300","wikidata":"https://www.wikidata.org/wiki/Q1134348","display_name":"Volumetric flow rate","level":2,"score":0.36899998784065247},{"id":"https://openalex.org/C16838498","wikidata":"https://www.wikidata.org/wiki/Q5101828","display_name":"Chiral column chromatography","level":3,"score":0.3449999988079071},{"id":"https://openalex.org/C10390740","wikidata":"https://www.wikidata.org/wiki/Q2282401","display_name":"Analyte","level":2,"score":0.3400999903678894},{"id":"https://openalex.org/C156217769","wikidata":"https://www.wikidata.org/wiki/Q1050046","display_name":"Chiral resolution","level":3,"score":0.3287999927997589},{"id":"https://openalex.org/C2780071497","wikidata":"https://www.wikidata.org/wiki/Q2746231","display_name":"Chloroformate","level":2,"score":0.313400000333786},{"id":"https://openalex.org/C179998833","wikidata":"https://www.wikidata.org/wiki/Q381233","display_name":"High-performance liquid chromatography","level":2,"score":0.3046000003814697},{"id":"https://openalex.org/C106186310","wikidata":"https://www.wikidata.org/wiki/Q1437823","display_name":"Pharmaceutical formulation","level":2,"score":0.2770000100135803},{"id":"https://openalex.org/C3020018676","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Retention time","level":2,"score":0.27469998598098755},{"id":"https://openalex.org/C45904493","wikidata":"https://www.wikidata.org/wiki/Q912807","display_name":"Active ingredient","level":2,"score":0.2743000090122223},{"id":"https://openalex.org/C2992520659","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatographic separation","level":3,"score":0.26579999923706055},{"id":"https://openalex.org/C64452783","wikidata":"https://www.wikidata.org/wiki/Q1524945","display_name":"Ternary operation","level":2,"score":0.25769999623298645},{"id":"https://openalex.org/C2780232233","wikidata":"https://www.wikidata.org/wiki/Q898987","display_name":"Separation process","level":2,"score":0.257099986076355},{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.25589999556541443},{"id":"https://openalex.org/C40834362","wikidata":"https://www.wikidata.org/wiki/Q184893","display_name":"Horizontal scan rate","level":5,"score":0.25290000438690186}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.22159/ijap.2026v18i6.59307","doi":"https://doi.org/10.22159/ijap.2026v18i6.59307","is_oa":true,"landing_page_url":"https://doi.org/10.22159/ijap.2026v18i6.59307","pdf_url":"https://journals.innovareacademics.in/index.php/ijap/article/download/59307/34565","source":{"id":"https://openalex.org/S2764477652","display_name":"International Journal of Applied Pharmaceutics","issn_l":"0975-7058","issn":["0975-7058"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":["poland-100","russia-white-list-3"],"host_organization":"https://openalex.org/P4322697801","host_organization_name":"Innovare Academic Sciences","host_organization_lineage":["https://openalex.org/P4322697801"],"host_organization_lineage_names":["Innovare Academic Sciences"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Applied Pharmaceutics","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.22159/ijap.2026v18i6.59307","doi":"https://doi.org/10.22159/ijap.2026v18i6.59307","is_oa":true,"landing_page_url":"https://doi.org/10.22159/ijap.2026v18i6.59307","pdf_url":"https://journals.innovareacademics.in/index.php/ijap/article/download/59307/34565","source":{"id":"https://openalex.org/S2764477652","display_name":"International Journal of Applied Pharmaceutics","issn_l":"0975-7058","issn":["0975-7058"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":["poland-100","russia-white-list-3"],"host_organization":"https://openalex.org/P4322697801","host_organization_name":"Innovare Academic Sciences","host_organization_lineage":["https://openalex.org/P4322697801"],"host_organization_lineage_names":["Innovare Academic Sciences"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Applied Pharmaceutics","raw_type":"journal-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7225560215.pdf","grobid_xml":"https://content.openalex.org/works/W7225560215.grobid-xml"},"referenced_works_count":23,"referenced_works":["https://openalex.org/W1992404453","https://openalex.org/W2048058024","https://openalex.org/W2088282077","https://openalex.org/W2396895550","https://openalex.org/W2788218532","https://openalex.org/W3134524629","https://openalex.org/W3168257410","https://openalex.org/W4293827624","https://openalex.org/W4321018638","https://openalex.org/W4362506540","https://openalex.org/W4386154037","https://openalex.org/W4389991722","https://openalex.org/W4392575603","https://openalex.org/W4396777990","https://openalex.org/W4403964704","https://openalex.org/W4404292859","https://openalex.org/W4404598458","https://openalex.org/W4407853653","https://openalex.org/W4407926632","https://openalex.org/W4408508521","https://openalex.org/W4408535067","https://openalex.org/W4412914674","https://openalex.org/W7220447913"],"related_works":["https://openalex.org/W7224722634","https://openalex.org/W4380550819","https://openalex.org/W3212924687","https://openalex.org/W4378528869","https://openalex.org/W7212066747","https://openalex.org/W4283269920","https://openalex.org/W2015327507","https://openalex.org/W2073696170","https://openalex.org/W3097542462","https://openalex.org/W2020475294"],"abstract_inverted_index":{"Objective:":[0],"Quality":[1],"by":[2],"Design":[3],"(QbD)":[4],"was":[5,59,76,148,169,184],"used":[6],"to":[7,155,204],"develop,":[8],"test,":[9],"and":[10,28,32,85,100,107,112,122,128,136,177,189,229,236,246],"optimize":[11],"a":[12,143,159],"reliable":[13],"normal":[14],"phase":[15],"high-performance":[16],"liquid":[17],"chromatography":[18],"(NP-HPLC)":[19],"method":[20,242],"for":[21,61,133,138,195],"distinguishing":[22],"R-and":[23,78],"S-isomers":[24,79],"in":[25],"bulk":[26],"pharmaceutical":[27],"therapeutic":[29],"formulations.":[30],"Separating":[31],"quantifying":[33],"the":[34,38,180,213,250],"enantiomers":[35],"of":[36,69,88,120,145,162,175,212,249],"Jaypirca,":[37],"next-generation":[39],"non-covalent":[40],"Bruton\u2019s":[41],"Tyrosine":[42],"Kinase":[43],"(BTK)":[44],"inhibitor,":[45],"is":[46],"essential.":[47],"Methods:":[48],"A":[49],"YMC":[50],"Chiral":[51],"ART":[52],"Cellulose-SC":[53],"column":[54],"(250\u00d74.6":[55],"mm,":[56],"5":[57,147],"\u00b5m)":[58],"utilized":[60],"chromatographic":[62],"separation.":[63],"At":[64],"35":[65],"\u00b0C,":[66],"1.5":[67],"ml/min":[68],"acetonitrile":[70,98],"with":[71,117,158,172,187,197,199,216],"0.1%":[72],"diethylamine":[73],"(100:0.1":[74],"v/v)":[75],"added.":[77],"showed":[80,96,124,193],"symmetrical":[81],"peaks":[82],"at":[83],"4.42":[84],"6.21":[86],"min":[87],"retention":[89,105,134],"time.":[90],"The":[91,165,206,239],"3\u00b2":[92],"full":[93],"factorial":[94],"design":[95],"that":[97],"composition":[99],"flow":[101],"rate":[102],"greatly":[103],"affected":[104],"time":[106,135],"resolution":[108,144],"(Model":[109],"F-values":[110],"674.76":[111],"1177.55;":[113],"p=0.0001).":[114],"Results:":[115],"Models":[116],"precision":[118],"ratios":[119,174],"61.29":[121],"75.35":[123],"high":[125],"signal":[126],"dependability":[127],"excellent":[129],"data":[130],"fit":[131],"(R\u00b2=0.9985":[132],"0.9986":[137],"resolution).":[139],"Under":[140],"optimal":[141],"conditions,":[142],"over":[146],"regularly":[149],"reached,":[150],"observed":[151],"linearity":[152],"across":[153],"1.0":[154,170],"3.5":[156],"\u00b5g/ml":[157,171,186],"R\u00b2":[160],"value":[161],"above":[163],"0.9999.":[164],"quantification":[166],"limit":[167,182],"(LOQ)":[168],"signal-to-noise":[173],"18.05":[176],"13.54,":[178],"while":[179],"detection":[181],"(LOD)":[183],"0.5":[185],"6.34":[188],"4.71.":[190],"Precision":[191],"experiments":[192],"%RSD<2%":[194],"suitability":[196],"system,":[198],"accuracy":[200],"ranging":[201],"from":[202],"98.1":[203],"101.8%.":[205],"Jaypirca":[207],"tablet":[208],"assay":[209],"recovered":[210],"99.7%":[211],"active":[214,252],"S-isomer":[215],"m/z":[217],"480.15\u2192400.02.":[218],"Conclusion:":[219],"Beyond":[220],"quality":[221],"monitoring,":[222],"chiral":[223],"separation":[224],"supports":[225],"regulatory":[226],"compliance,":[227],"stability":[228],"racemization":[230],"studies,":[231],"impurity":[232],"profiling,":[233],"process":[234],"optimization,":[235],"stereoselective":[237],"synthesis.":[238],"validated":[240],"NP-HPLC":[241],"ensures":[243],"enantiomeric":[244],"purity":[245],"selective":[247],"production":[248],"pharmacologically":[251],"S-isomer.":[253]},"counts_by_year":[],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2026-11-09T00:00:00"}
