{"id":"https://openalex.org/W7224815811","doi":"https://doi.org/10.5281/zenodo.23796033","title":"ANALYTICAL METHOD DEVELOPMENT AND FORCE DEGRADATION STUDIES OF ANALYTICAL QUALITY BY DESIGN (AQBD) BASED OPTIMIZATION OFA RP-UPLC METHOD FOR DETERMINATION OF NIVOLUMAB INJECTION","display_name":"ANALYTICAL METHOD DEVELOPMENT AND FORCE DEGRADATION STUDIES OF ANALYTICAL QUALITY BY DESIGN (AQBD) BASED OPTIMIZATION OFA RP-UPLC METHOD FOR DETERMINATION OF NIVOLUMAB INJECTION","publication_year":2026,"publication_date":"2026-11-01","ids":{"openalex":"https://openalex.org/W7224815811","doi":"https://doi.org/10.5281/zenodo.23796033"},"language":"en","primary_location":{"id":"doi:10.5281/zenodo.23796033","doi":"https://doi.org/10.5281/zenodo.23796033","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23796033","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"volume":null,"type":"article","indexed_in":["datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.5281/zenodo.23796033","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5160202942","display_name":"V. Deepika*1, M. Hima Bindu2, Dr. Achari Kandukuri Triveni3, N. Vijaya Lakshmi Reddy4","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"V. Deepika*1, M. Hima Bindu2, Dr. Achari Kandukuri Triveni3, N. Vijaya Lakshmi Reddy4","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5160202942"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.72484169,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.9940999746322632,"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/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.9940999746322632,"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/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.003800000064074993,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11124","display_name":"Protein purification and stability","score":0.000699999975040555,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/rp-uplc-method-development","display_name":"RP-UPLC method development","score":0.7730000019073486},{"id":"https://openalex.org/keywords/analytical-quality-by-design","display_name":"analytical quality by design","score":0.8859999775886536},{"id":"https://openalex.org/keywords/central-composite-design","display_name":"central composite design","score":0.875},{"id":"https://openalex.org/keywords/method-optimization","display_name":"method optimization","score":0.7699999809265137},{"id":"https://openalex.org/keywords/forced-degradation","display_name":"forced degradation","score":0.6510000228881836},{"id":"https://openalex.org/keywords/stability-indicating-method","display_name":"stability-indicating assay","score":0.949999988079071},{"id":"https://openalex.org/keywords/monoclonal-antibodies","display_name":"monoclonal antibodies","score":0.8119999766349792},{"id":"https://openalex.org/keywords/method-validation","display_name":"method validation","score":0.4569999873638153},{"id":"https://openalex.org/keywords/retention-time","display_name":"retention time","score":0.38999998569488525},{"id":"https://openalex.org/keywords/tailing-factor","display_name":"tailing factor","score":0.48500001430511475},{"id":"https://openalex.org/keywords/column-temperature","display_name":"column temperature","score":0.3070000112056732}],"concepts":[{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.7105000019073486},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.5594000220298767},{"id":"https://openalex.org/C63479239","wikidata":"https://www.wikidata.org/wiki/Q7353546","display_name":"Robustness (evolution)","level":3,"score":0.47780001163482666},{"id":"https://openalex.org/C21880701","wikidata":"https://www.wikidata.org/wiki/Q2144042","display_name":"Process engineering","level":1,"score":0.4756999909877777},{"id":"https://openalex.org/C77170095","wikidata":"https://www.wikidata.org/wiki/Q1753188","display_name":"Linearity","level":2,"score":0.46000000834465027},{"id":"https://openalex.org/C2779607525","wikidata":"https://www.wikidata.org/wiki/Q14982","display_name":"Methanol","level":2,"score":0.45969998836517334},{"id":"https://openalex.org/C192562407","wikidata":"https://www.wikidata.org/wiki/Q228736","display_name":"Materials science","level":0,"score":0.45249998569488525},{"id":"https://openalex.org/C2779679103","wikidata":"https://www.wikidata.org/wiki/Q5251805","display_name":"Degradation (telecommunications)","level":2,"score":0.4366999864578247},{"id":"https://openalex.org/C34559072","wikidata":"https://www.wikidata.org/wiki/Q2334061","display_name":"Design of experiments","level":2,"score":0.4027000069618225},{"id":"https://openalex.org/C2780030458","wikidata":"https://www.wikidata.org/wiki/Q7041828","display_name":"Nivolumab","level":4,"score":0.3962000012397766},{"id":"https://openalex.org/C177212765","wikidata":"https://www.wikidata.org/wiki/Q627335","display_name":"Workflow","level":2,"score":0.3944000005722046},{"id":"https://openalex.org/C92397422","wikidata":"https://www.wikidata.org/wiki/Q5062082","display_name":"Central composite design","level":3,"score":0.39079999923706055},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.36899998784065247},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.35350000858306885},{"id":"https://openalex.org/C3020018676","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Retention time","level":2,"score":0.3490000069141388},{"id":"https://openalex.org/C138268822","wikidata":"https://www.wikidata.org/wiki/Q1051925","display_name":"Resolution (logic)","level":2,"score":0.3488999903202057},{"id":"https://openalex.org/C2777682752","wikidata":"https://www.wikidata.org/wiki/Q8564473","display_name":"Forced degradation","level":4,"score":0.3393999934196472},{"id":"https://openalex.org/C172120300","wikidata":"https://www.wikidata.org/wiki/Q1134348","display_name":"Volumetric flow rate","level":2,"score":0.3294000029563904},{"id":"https://openalex.org/C150077022","wikidata":"https://www.wikidata.org/wiki/Q3136137","display_name":"Response surface methodology","level":2,"score":0.3043999969959259},{"id":"https://openalex.org/C179998833","wikidata":"https://www.wikidata.org/wiki/Q381233","display_name":"High-performance liquid chromatography","level":2,"score":0.3005000054836273},{"id":"https://openalex.org/C44280652","wikidata":"https://www.wikidata.org/wiki/Q104837","display_name":"Phase (matter)","level":2,"score":0.2808000147342682},{"id":"https://openalex.org/C113196181","wikidata":"https://www.wikidata.org/wiki/Q485223","display_name":"Analytical Chemistry (journal)","level":2,"score":0.2694000005722046},{"id":"https://openalex.org/C3020199158","wikidata":"https://www.wikidata.org/wiki/Q210521","display_name":"High resolution","level":2,"score":0.25870001316070557},{"id":"https://openalex.org/C2780551164","wikidata":"https://www.wikidata.org/wiki/Q2306599","display_name":"Column (typography)","level":3,"score":0.25859999656677246},{"id":"https://openalex.org/C112972136","wikidata":"https://www.wikidata.org/wiki/Q7595718","display_name":"Stability (learning theory)","level":2,"score":0.25200000405311584}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.5281/zenodo.23796033","doi":"https://doi.org/10.5281/zenodo.23796033","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23796033","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},{"id":"doi:10.5281/zenodo.23796034","doi":"https://doi.org/10.5281/zenodo.23796034","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23796034","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"}],"best_oa_location":{"id":"doi:10.5281/zenodo.23796033","doi":"https://doi.org/10.5281/zenodo.23796033","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23796033","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.4043000042438507}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W7218861636","https://openalex.org/W4400496441","https://openalex.org/W7223398322","https://openalex.org/W7127328794","https://openalex.org/W6911690734","https://openalex.org/W4408687223","https://openalex.org/W4308009641","https://openalex.org/W4387318561","https://openalex.org/W7221314627","https://openalex.org/W7167594550"],"abstract_inverted_index":{"Nivolumab":[0,49],"is":[1],"a":[2,35,111,118,130],"pioneering":[3],"fully":[4],"human":[5],"IgG4":[6],"monoclonal":[7],"antibody":[8],"checkpoint":[9],"inhibitor":[10],"that":[11],"has":[12],"revolutionized":[13],"oncology.":[14],"Traditional":[15],"analytical":[16,96],"workflows":[17],"often":[18],"lack":[19],"the":[20,32,73,82,191],"systematic":[21],"robustness":[22],"required":[23],"for":[24,48],"such":[25],"complex":[26],"macromolecular":[27],"formulations.":[28],"This":[29],"study":[30],"describes":[31],"development":[33],"of":[34,84,121,133,153,187],"highly":[36],"robust,":[37],"sensitive,":[38],"and":[39,91,103,127,140,170],"rapid":[40],"stability-indicating":[41],"reversed-phase":[42],"ultra-performance":[43],"liquid":[44],"chromatography":[45],"(RP-UPLC)":[46],"method":[47,74,147],"Injection":[50],"optimized":[51],"via":[52],"Analytical":[53],"Quality":[54],"by":[55],"Design":[56,64],"(AQbD)":[57],"principles.":[58],"A":[59],"five-level,":[60],"three-factor":[61],"Central":[62],"Composite":[63],"(CCD)":[65],"was":[66,108],"implemented":[67],"using":[68,117],"Design-Expert\u00ae":[69],"software":[70],"to":[71,174],"explore":[72],"operable":[75],"design":[76],"region.":[77],"Mathematical":[78],"models":[79],"systematically":[80],"evaluated":[81],"effects":[83],"flow":[85,131],"rate,":[86],"mobile":[87,119],"phase":[88,120],"methanol":[89,128],"percentage,":[90],"column":[92,116,138],"temperature":[93],"on":[94,110],"critical":[95],"responses,":[97],"including":[98],"retention":[99,151],"time,":[100],"theoretical":[101],"plates,":[102],"tailing":[104],"factor.":[105],"Optimized":[106],"separation":[107],"achieved":[109],"waters":[112],"UPLC":[113],"BEH":[114],"C18":[115],"0.1%":[122],"orthophosphoric":[123],"acid":[124],"(pH":[125],"3.00)":[126],"at":[129,143],"rate":[132],"0.3":[134],"mL/min,":[135],"30":[136],"\u00b0C":[137],"temperature,":[139],"UV":[141],"detection":[142],"280":[144],"nm.":[145],"The":[146],"yielded":[148],"an":[149],"ultrafast":[150],"time":[152],"0.512":[154],"minutes.":[155],"Validation":[156],"per":[157],"ICH":[158],"guidelines":[159],"demonstrated":[160],"excellent":[161,181],"linearity":[162],"(10%\u2013200%),":[163],"high":[164],"accuracy":[165],"with":[166],"recoveries":[167],"spanning":[168],"99.6%\u2013100.2%,":[169],"sample":[171],"stability":[172],"up":[173],"48":[175],"hours.":[176],"Forced":[177],"degradation":[178],"studies":[179],"confirmed":[180],"specificity,":[182],"ensuring":[183],"complete":[184],"baseline":[185],"resolution":[186],"stress-induced":[188],"degradants":[189],"from":[190],"intact":[192],"active":[193],"peak.":[194]},"counts_by_year":[],"updated_date":"2026-11-01T11:40:01.658920","created_date":"2026-10-31T00:00:00"}