{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T04:48:51Z","timestamp":1780721331936,"version":"3.54.1"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2021,12,22]],"date-time":"2021-12-22T00:00:00Z","timestamp":1640131200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,11,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Zanubrutinib is an unfamiliar second generation selective Brutson\u2019s Tyrosine Kinase inhibitor used to treat mantle cell lymphoma. In the present analysis, a new, stability indicating reverse-phase, high performance liquid chromatography method was developed and validated for the determination of Zanubrutinib succeeding degradation studies as pert the International Conference on Harmonization guidelines. The chromatographic separation of Zanubrutinib was achieved in a C18 column (250\u2009\u00d7\u20094.6\u00a0mm, 5-\u03bcm particle size) using a mobile phase of Acetonitrile: 0.1% Tri Ethyl Amine (65:35\u00a0v\/v) monitored at 219\u00a0nm. The forced degradation studies were conducted by exposing the analyte to acidic, alkaline and neutral hydrolysis, oxidative, reductive, photolytic, and thermal stress conditions and the degradation behavior was studied. The analyte showed degradation under acidic, alkaline, oxidative and reductive stress conditions with additional peaks but, it was stable under neutral, photolytic and thermal stress conditions. The developed method was extended to triple quadruple mass spectrometry to characterize degradation products and to study the fragmentation pattern. Total four degradants were characterized including DP1 in acid &amp;base hydrolysis, DP2 in oxidative and DP3, DP4 in reductive stress condition. As no substantial method was available for quantification of Zanubrutinib and to characterize zanubrutinib degradants, this method can be used for regular analysis in quality control labs.<\/jats:p>","DOI":"10.1093\/chromsci\/bmab137","type":"journal-article","created":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T12:11:07Z","timestamp":1637755867000},"page":"807-816","source":"Crossref","is-referenced-by-count":6,"title":["Forced Degradation Study of Zanubrutinib: An LC\u2013PDA and LC\u2013MS Approach"],"prefix":"10.1093","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5203-7839","authenticated-orcid":false,"given":"Gowri","family":"Gollu","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India"},{"name":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sowjanya","family":"Gummadi","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis , , Visakhapatnam, 530045, Andhra Pradesh, India"},{"name":"GITAM Institute of Pharmacy, GITAM (Deemed to be University) , , Visakhapatnam, 530045, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Venkata Deepthi","family":"Vemuri","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India"},{"name":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swathi","family":"Nalla","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India"},{"name":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nalini","family":"Mathala","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India"},{"name":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sasikala","family":"Allam","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis , , Vizianagaram, 535002, Andhra Pradesh, India"},{"name":"Maharajah\u2019s College of Pharmacy, Phool Baugh , , Vizianagaram, 535002, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,12,22]]},"reference":[{"key":"2022110707382243200_ref1","first-page":"4483","article-title":"Mantle cell lymphoma-an entity comes of age","volume":"87","author":"Dennis","year":"1996","journal-title":"Blood; American Journal of Hematology"},{"key":"2022110707382243200_ref2","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1200\/JCO.2012.44.4281","article-title":"Targeting B-Cell receptor signaling for anticancer therapy: the Bruton's tyrosine kinase inhibitor ibrutinib induces impressive responses in B-cell malignancies","volume":"31","author":"Wiestner","year":"2013","journal-title":"Journal of Clinical Oncology"},{"key":"2022110707382243200_ref3","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1038\/nature08638","article-title":"Chronic active B-cell-receptor signalling in diffuse large B-cell lymphoma","volume":"463","author":"Davis","year":"2010","journal-title":"Nature"},{"key":"2022110707382243200_ref4","doi-asserted-by":"crossref","first-page":"3339","DOI":"10.3892\/ol.2015.3802","article-title":"Targeting Bruton's tyrosine kinase signalling as an emerging therapeutic agent of B-cell malignancies","volume":"10","author":"Bing","year":"2015","journal-title":"Oncology Letters"},{"key":"2022110707382243200_ref5","doi-asserted-by":"crossref","first-page":"119","DOI":"10.3109\/08830185.2012.664797","article-title":"Bruton tyrosine kinase (BTK) and its role in B-cell malignancy","volume":"31","author":"Buggy","year":"2012","journal-title":"International Reviews of Immunology"},{"key":"2022110707382243200_ref6","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1038\/nrd3656","article-title":"Trial watch: BTK inhibitor shows positive results in B cell malignancies","volume":"11","author":"Harrison","year":"2012","journal-title":"Nature Reviews. Drug Discovery"},{"key":"2022110707382243200_ref7","doi-asserted-by":"crossref","first-page":"203","DOI":"10.18632\/oncotarget.426","article-title":"Novel targeted therapies for mantle cell lymphoma","volume":"3","author":"Alinari","year":"2012","journal-title":"Oncotarget"},{"key":"2022110707382243200_ref8","doi-asserted-by":"crossref","first-page":"7923","DOI":"10.1021\/acs.jmedchem.9b00687","article-title":"Discovery of Zanubrutinib (BGB-3111), a novel, potent, and selective covalent inhibitor of Bruton's tyrosine kinase","volume":"62","author":"Yunhang","year":"2019","journal-title":"Journal of Medicinal Chemistry"},{"key":"2022110707382243200_ref9","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1007\/s40265-019-01252-4","article-title":"Zanubrutinib: First approval","volume":"80","author":"Yahiya","year":"2020","journal-title":"Drugs"},{"key":"2022110707382243200_ref10","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1016\/j.trac.2013.06.001","article-title":"The role of analytical chemistry in drug stability studies","volume":"49","author":"Gorog","year":"2013","journal-title":"Trends Analyti Chem"},{"key":"2022110707382243200_ref11","volume-title":"Q1A (R2) Stability Testing of New Drug Substances and Products (International Conference on Harmonization), IFPMA","author":"ICH guideline","year":"2003"},{"key":"2022110707382243200_ref12","first-page":"33","article-title":"LC, MSn and LC-MS\/MS studies for the characterization of degradation products of amlodipine","volume":"5","author":"Ravi","year":"2015","journal-title":"JPA"},{"key":"2022110707382243200_ref13","first-page":"357","article-title":"LC-MS\/MS studies for the identification and characterization of degradation products of acebutolol","volume":"8","author":"Uday","year":"2018","journal-title":"JPA"},{"key":"2022110707382243200_ref14","doi-asserted-by":"crossref","first-page":"1771","DOI":"10.3390\/molecules23071771","article-title":"Development of validated and stability-indicating lc-dad and lc-ms\/ms methods for determination of avanafil in pharmaceutical preparations and identification of a novel degradation product by LCMS-IT-TOF","volume":"23","author":"Nafiz","year":"2018","journal-title":"Molecules"},{"key":"2022110707382243200_ref15","first-page":"712","article-title":"A novel stability indicating analytical development and validation of a RP-HPLC assay method for the quantification of ibrutinib in bulk and its formulation","volume":"11","author":"Muneer","year":"2017","journal-title":"JPRS."},{"key":"2022110707382243200_ref16","first-page":"22","article-title":"Bioanalytical method development and validation of ibrutinib in biological matrices by LC\u2013MS\/MS","volume":"11","author":"Ashok Kumar","year":"2019","journal-title":"International Journal of Pharmacy and Pharmaceutical Science"},{"key":"2022110707382243200_ref17","volume-title":"International Conference on Harmonization","author":"ICH guideline Validation of Analytical Procedures: Text and Methodology Q2 (R1)","year":"1996"},{"key":"2022110707382243200_ref18","volume-title":"USP General Chapter, USP&lt;1225&gt; Validation of Compendial","author":"United States Pharmacopeia","year":"2019"},{"key":"2022110707382243200_ref19","article-title":"Principles of chromatography method development","author":"Narasimha","year":"2019","journal-title":"Intech Open, London."}],"container-title":["Journal of Chromatographic Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/60\/9\/807\/46822262\/bmab137.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/60\/9\/807\/46822262\/bmab137.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,7]],"date-time":"2022-11-07T07:39:19Z","timestamp":1667806759000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/chromsci\/article\/60\/9\/807\/6474508"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12,22]]},"references-count":19,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2021,12,22]]},"published-print":{"date-parts":[[2022,11,5]]}},"URL":"https:\/\/doi.org\/10.1093\/chromsci\/bmab137","relation":{},"ISSN":["0021-9665","1945-239X"],"issn-type":[{"value":"0021-9665","type":"print"},{"value":"1945-239X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,10]]},"published":{"date-parts":[[2021,12,22]]}}}