{"id":"https://openalex.org/W4200529265","doi":"https://doi.org/10.1093/chromsci/bmab137","title":"Forced Degradation Study of Zanubrutinib: An LC\u2013PDA and LC\u2013MS Approach","display_name":"Forced Degradation Study of Zanubrutinib: An LC\u2013PDA and LC\u2013MS Approach","publication_year":2021,"publication_date":"2021-11-24","ids":{"openalex":"https://openalex.org/W4200529265","doi":"https://doi.org/10.1093/chromsci/bmab137","pmid":"https://pubmed.ncbi.nlm.nih.gov/34933329"},"language":"en","primary_location":{"id":"doi:10.1093/chromsci/bmab137","doi":"https://doi.org/10.1093/chromsci/bmab137","is_oa":false,"landing_page_url":"https://doi.org/10.1093/chromsci/bmab137","pdf_url":null,"source":{"id":"https://openalex.org/S144192255","display_name":"Journal of Chromatographic Science","issn_l":"0021-9665","issn":["0021-9665","1945-239X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","jufo-1","medline","norway-1","poland-40","russia-white-list-3"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Chromatographic Science","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5077787865","display_name":"Gowri Gollu","orcid":"https://orcid.org/0000-0002-5203-7839","observed_orcids":["https://orcid.org/0000-0002-5203-7839"]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Gowri Gollu","raw_affiliation_strings":["Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"],"raw_orcid":"https://orcid.org/0000-0002-5203-7839","affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]},{"raw_affiliation_string":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010414367","display_name":"Sowjanya Gummadi","orcid":"https://orcid.org/0000-0002-5561-6502","observed_orcids":["https://orcid.org/0000-0002-5561-6502"]},"institutions":[{"id":"https://openalex.org/I885392262","display_name":"GITAM University","ror":"https://ror.org/0440p1d37","country_code":"IN","type":"education","lineage":["https://openalex.org/I885392262"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Sowjanya Gummadi","raw_affiliation_strings":["Department of Pharmaceutical Analysis , , Visakhapatnam, 530045, Andhra Pradesh, India","GITAM Institute of Pharmacy, GITAM (Deemed to be University) , , Visakhapatnam, 530045, Andhra Pradesh, India","Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, 530045, Andhra Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical Analysis , , Visakhapatnam, 530045, Andhra Pradesh, India","institution_ids":[]},{"raw_affiliation_string":"GITAM Institute of Pharmacy, GITAM (Deemed to be University) , , Visakhapatnam, 530045, Andhra Pradesh, India","institution_ids":["https://openalex.org/I885392262"]},{"raw_affiliation_string":"Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, 530045, Andhra Pradesh, India","institution_ids":["https://openalex.org/I885392262"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5025478511","display_name":"Venkata Deepthi Vemuri","orcid":"https://orcid.org/0000-0003-3243-4340","observed_orcids":["https://orcid.org/0000-0003-3243-4340"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Venkata Deepthi Vemuri","raw_affiliation_strings":["Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]},{"raw_affiliation_string":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5060030429","display_name":"Swathi Nalla","orcid":"https://orcid.org/0000-0002-0605-1955","observed_orcids":["https://orcid.org/0000-0002-0605-1955"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Swathi Nalla","raw_affiliation_strings":["Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]},{"raw_affiliation_string":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5026591692","display_name":"Nalini Mathala","orcid":"https://orcid.org/0000-0002-1634-5906","observed_orcids":["https://orcid.org/0000-0002-1634-5906"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Nalini Mathala","raw_affiliation_strings":["Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]},{"raw_affiliation_string":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5084566802","display_name":"Allam Sasikala","orcid":"https://orcid.org/0000-0001-9583-9834","observed_orcids":["https://orcid.org/0000-0001-9583-9834"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Sasikala Allam","raw_affiliation_strings":["Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]},{"raw_affiliation_string":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5077787865"],"corresponding_institution_ids":[],"apc_list":{"value":4143,"currency":"USD","value_usd":4143},"apc_paid":null,"fwci":0.3547,"has_fulltext":false,"cited_by_count":6,"citation_normalized_percentile":{"value":0.50315891,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":97},"biblio":{"volume":"60","issue":"9","first_page":"807","last_page":"816"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":1.0,"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":1.0,"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":0.0,"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/T11423","display_name":"Pesticide Residue Analysis and Safety","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1106","display_name":"Food Science"},"field":{"id":"https://openalex.org/fields/11","display_name":"Agricultural and Biological Sciences"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/zanubrutinib","display_name":"zanubrutinib","score":1.0},{"id":"https://openalex.org/keywords/forced-degradation","display_name":"forced degradation","score":0.984000027179718},{"id":"https://openalex.org/keywords/stability-indicating-method","display_name":"stability-indicating assay","score":0.8169999718666077},{"id":"https://openalex.org/keywords/degradation-products","display_name":"degradation products","score":0.7250000238418579},{"id":"https://openalex.org/keywords/bruton-tyrosine-kinase-inhibitors","display_name":"BTK inhibitors","score":0.9340000152587891},{"id":"https://openalex.org/keywords/mantle-cell-lymphoma","display_name":"mantle cell lymphoma","score":0.8489999771118164},{"id":"https://openalex.org/keywords/oxidative-degradation","display_name":"oxidative degradation","score":0.8690000176429749},{"id":"https://openalex.org/keywords/reductive-degradation","display_name":"reductive degradation","score":0.9819999933242798},{"id":"https://openalex.org/keywords/photolytic-degradation","display_name":"photolytic degradation","score":0.6819999814033508},{"id":"https://openalex.org/keywords/thermal-degradation","display_name":"thermal degradation","score":0.9810000061988831},{"id":"https://openalex.org/keywords/fragmentation-patterns","display_name":"fragmentation patterns","score":0.5009999871253967},{"id":"https://openalex.org/keywords/pharmaceutical-quality-control","display_name":"pharmaceutical quality control","score":0.6420000195503235}],"concepts":[{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.8963534832000732},{"id":"https://openalex.org/C2777682752","wikidata":"https://www.wikidata.org/wiki/Q8564473","display_name":"Forced degradation","level":4,"score":0.6912517547607422},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.6252953410148621},{"id":"https://openalex.org/C94412978","wikidata":"https://www.wikidata.org/wiki/Q103135","display_name":"Hydrolysis","level":2,"score":0.5630837678909302},{"id":"https://openalex.org/C2779679103","wikidata":"https://www.wikidata.org/wiki/Q5251805","display_name":"Degradation (telecommunications)","level":2,"score":0.43820920586586},{"id":"https://openalex.org/C2777463227","wikidata":"https://www.wikidata.org/wiki/Q408047","display_name":"Acetonitrile","level":2,"score":0.41269126534461975},{"id":"https://openalex.org/C179998833","wikidata":"https://www.wikidata.org/wiki/Q381233","display_name":"High-performance liquid chromatography","level":2,"score":0.2380674183368683},{"id":"https://openalex.org/C45188465","wikidata":"https://www.wikidata.org/wiki/Q645497","display_name":"Reversed-phase chromatography","level":3,"score":0.218417227268219},{"id":"https://openalex.org/C178790620","wikidata":"https://www.wikidata.org/wiki/Q11351","display_name":"Organic chemistry","level":1,"score":0.1994081735610962},{"id":"https://openalex.org/C76155785","wikidata":"https://www.wikidata.org/wiki/Q418","display_name":"Telecommunications","level":1,"score":0.0},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D002851","descriptor_name":"Chromatography, High Pressure Liquid","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002851","descriptor_name":"Chromatography, High Pressure Liquid","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002851","descriptor_name":"Chromatography, High Pressure Liquid","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002853","descriptor_name":"Chromatography, Liquid","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002853","descriptor_name":"Chromatography, Liquid","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002853","descriptor_name":"Chromatography, Liquid","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D004355","descriptor_name":"Drug Stability","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004355","descriptor_name":"Drug Stability","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004355","descriptor_name":"Drug Stability","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010880","descriptor_name":"Piperidines","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D010880","descriptor_name":"Piperidines","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D010880","descriptor_name":"Piperidines","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011720","descriptor_name":"Pyrazoles","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011743","descriptor_name":"Pyrimidines","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D053719","descriptor_name":"Tandem Mass Spectrometry","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D053719","descriptor_name":"Tandem Mass Spectrometry","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D053719","descriptor_name":"Tandem Mass Spectrometry","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1093/chromsci/bmab137","doi":"https://doi.org/10.1093/chromsci/bmab137","is_oa":false,"landing_page_url":"https://doi.org/10.1093/chromsci/bmab137","pdf_url":null,"source":{"id":"https://openalex.org/S144192255","display_name":"Journal of Chromatographic Science","issn_l":"0021-9665","issn":["0021-9665","1945-239X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","jufo-1","medline","norway-1","poland-40","russia-white-list-3"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Chromatographic Science","raw_type":"journal-article"},{"id":"pmid:34933329","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/34933329","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of chromatographic science","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[],"sustainable_development_goals_aurora":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":14,"referenced_works":["https://openalex.org/W1910349555","https://openalex.org/W1979816280","https://openalex.org/W2001618699","https://openalex.org/W2014064833","https://openalex.org/W2032482627","https://openalex.org/W2064862416","https://openalex.org/W2146029333","https://openalex.org/W2154945466","https://openalex.org/W2241314352","https://openalex.org/W2884194601","https://openalex.org/W2918801675","https://openalex.org/W2972482801","https://openalex.org/W2981745522","https://openalex.org/W2998982556"],"related_works":["https://openalex.org/W2018522840","https://openalex.org/W4322007804","https://openalex.org/W4312089461","https://openalex.org/W2599388867","https://openalex.org/W2001281989","https://openalex.org/W4385713070","https://openalex.org/W1506783248","https://openalex.org/W3040012780","https://openalex.org/W2189507414","https://openalex.org/W2189305301"],"abstract_inverted_index":{"Zanubrutinib":[0,39,55,190],"is":[1],"an":[2],"unfamiliar":[3],"second":[4],"generation":[5],"selective":[6],"Brutson's":[7],"Tyrosine":[8],"Kinase":[9],"inhibitor":[10],"used":[11,200],"to":[12,95,145,150,155,192],"treat":[13],"mantle":[14],"cell":[15],"lymphoma.":[16],"In":[17],"the":[18,36,45,93,109,157],"present":[19],"analysis,":[20],"a":[21,59,70],"new,":[22],"stability":[23],"indicating":[24],"reverse-phase,":[25],"high":[26],"performance":[27],"liquid":[28],"chromatography":[29],"method":[30,142,184,197],"was":[31,56,112,131,143,185],"developed":[32,141],"and":[33,98,104,108,122,136,154,174,191],"validated":[34],"for":[35,187,201],"determination":[37],"of":[38,54,73,189],"succeeding":[40],"degradation":[41,87,110,117,152],"studies":[42,88],"as":[43],"pert":[44],"International":[46],"Conference":[47],"on":[48],"Harmonization":[49],"guidelines.":[50],"The":[51,85,114,140],"chromatographic":[52],"separation":[53],"achieved":[57],"in":[58,167,172,177,204],"C18":[60],"column":[61],"(250":[62],"\u00d7":[63],"4.6":[64],"mm,":[65],"5-\u03bcm":[66],"particle":[67],"size)":[68],"using":[69],"mobile":[71],"phase":[72],"Acetonitrile:":[74],"0.1%":[75],"Tri":[76],"Ethyl":[77],"Amine":[78],"(65:35":[79],"v/v)":[80],"monitored":[81],"at":[82],"219":[83],"nm.":[84],"forced":[86],"were":[89,163],"conducted":[90],"by":[91],"exposing":[92],"analyte":[94,115],"acidic,":[96,119],"alkaline":[97],"neutral":[99],"hydrolysis,":[100,170],"oxidative,":[101],"reductive,":[102],"photolytic,":[103],"thermal":[105,137],"stress":[106,124,138,179],"conditions":[107,125],"behavior":[111],"studied.":[113],"showed":[116],"under":[118,133],"alkaline,":[120],"oxidative":[121,173],"reductive":[123,178],"with":[126],"additional":[127],"peaks":[128],"but,":[129],"it":[130],"stable":[132],"neutral,":[134],"photolytic":[135],"conditions.":[139],"extended":[144],"triple":[146],"quadruple":[147],"mass":[148],"spectrometry":[149],"characterize":[151,193],"products":[153],"study":[156],"fragmentation":[158],"pattern.":[159],"Total":[160],"four":[161],"degradants":[162],"characterized":[164],"including":[165],"DP1":[166],"acid":[168],"&base":[169],"DP2":[171],"DP3,":[175],"DP4":[176],"condition.":[180],"As":[181],"no":[182],"substantial":[183],"available":[186],"quantification":[188],"zanubrutinib":[194],"degradants,":[195],"this":[196],"can":[198],"be":[199],"regular":[202],"analysis":[203],"quality":[205],"control":[206],"labs.":[207]},"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2025,"cited_by_count":1},{"year":2023,"cited_by_count":3}],"updated_date":"2026-10-13T10:08:12.033832","created_date":"2025-10-10T00:00:00"}
