{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T19:08:03Z","timestamp":1784833683891,"version":"3.55.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T00:00:00Z","timestamp":1784764800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Vignan\u2019s Foundation for Sciences, Technology and Research","award":["VFSTR\/REG\/A6\/30\/2023\u201324\/04"],"award-info":[{"award-number":["VFSTR\/REG\/A6\/30\/2023\u201324\/04"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The simultaneous determination of Abemaciclib and Olaparib in in-houseprepared tablets was accomplished by the development and validation of a novel and rapid and sensitive reverse-phase ultra-performance liquid chromatography (RP-UPLC) technique. Using a Waters X-Bridge C18 (4.6\u2009\u00d7\u2009100\u00a0mm, 3.5\u00a0\u03bcm) column and a mobile phase made up of 0.1% orthophosphoric acid in water, acetonitrile and methanol (70:20:10% v\/v\/v) in an isocratic elution mode at a flow rate of 1\u00a0mL\/min, the chromatographic separation was accomplished. High sensitivity and selectivity were made possible by performing the detection at 219\u00a0nm. Following ICH Q2(R1) criteria, the technique was validated and showed high linearity (R2\u2009&amp;gt;\u20090.999) for both drugs over the concentration range of 10\u201360\u00a0\u03bcg\/mL. Within acceptable boundaries (&amp;lt;2% Relative Standard deviation (RSD)), both intra-day and inter-day precision and accuracy (recovery percentage) were proven. Forced degradation studies confirmed the method\u2019s stability-indicating capability, Stability studies indicated significant degradation under acid, alkali, peroxide and thermal degradation conditions. The degradation products were characterized by LC\u2013MS technique, and possible degradation pathways were proposed. Additionally, in vitro pharmacokinetic evaluation, including dissolution and drug release kinetics, was performed to assess formulation performance. The developed method proved simple, precise and robust, making it suitable for routine quality control, stability study and pharmacokinetic studies of Abemaciclib and Olaparib co-formulated tablets.<\/jats:p>","DOI":"10.1093\/chromsci\/bmag022","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T17:59:48Z","timestamp":1784829588000},"source":"Crossref","is-referenced-by-count":0,"title":["Development of a stability-indicating RP-UPLC method for simultaneous determination of Abemaciclib and Olaparib with LC\u2013MS characterization of degradation products and\n                    <i>in vitro<\/i>\n                    performance evaluation"],"prefix":"10.1093","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8250-3570","authenticated-orcid":false,"given":"Sathish Kumar","family":"Konidala","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Biotechnology and Pharmaceutical Sciences, Vignan\u2019s Foundation for Science, Technology, and Research , Guntur 522213, Vadlamudi, Andhra Pradesh ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srikar","family":"Grandhi","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Biotechnology and Pharmaceutical Sciences, Vignan\u2019s Foundation for Science, Technology, and Research , Guntur 522213, Vadlamudi, Andhra Pradesh ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harsha Sri","family":"Kamma","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, School of Biotechnology and Pharmaceutical Sciences, Vignan\u2019s Foundation for Science, Technology, and Research , Guntur 522213, Vadlamudi, Andhra Pradesh ,","place":["India"]},{"name":"Department of Pharmaceutical Analysis, Vignan Pharmacy College , Vadlamudi, Guntur 522213, Andhra Pradesh ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,7,23]]},"reference":[{"issue":"1","key":"2026072314414548600_ref1","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1093\/carcin\/bgaa121","article-title":"An overview of cancer health disparities: New approaches and insights and why they matter","volume":"42","author":"Minas","year":"2021","journal-title":"Carcinogenesis"},{"issue":"10","key":"2026072314414548600_ref2","doi-asserted-by":"publisher","first-page":"1269","DOI":"10.3390\/biom14101269","article-title":"Poly (ADP-ribose) polymerase (PARP) inhibitors for cancer therapy: Advances, challenges, and future directions","volume":"14","author":"Bondar","year":"2024","journal-title":"Biomolecules"},{"key":"2026072314414548600_ref3","doi-asserted-by":"publisher","first-page":"1758835918808509","DOI":"10.1177\/1758835918808509","article-title":"Inhibitors targeting CDK4\/6, PARP and PI3K in breast cancer: A review","volume":"10","author":"NurHusna","year":"2018","journal-title":"Therapeutic Advances in Medical Oncology"},{"key":"2026072314414548600_ref4","doi-asserted-by":"publisher","first-page":"321","DOI":"10.2147\/DDDT.S137783","article-title":"Abemaciclib: A CDK4\/6 inhibitor for the treatment of HR+\/HER2\u2212 advanced breast cancer","volume":"Volume 12","author":"Corona","year":"2018","journal-title":"Drug Design, Development and Therapy"},{"key":"2026072314414548600_ref5","doi-asserted-by":"publisher","first-page":"1441222","DOI":"10.3389\/fonc.2024.1441222","article-title":"Combined strategies with PARP inhibitors for the treatment of BRCA wide type cancer","volume":"14","author":"Xie","year":"2024","journal-title":"Frontiers in Oncology"},{"key":"2026072314414548600_ref6","author":"National Cancer Institute","year":"2023"},{"key":"2026072314414548600_ref7","doi-asserted-by":"publisher","first-page":"420","DOI":"10.3389\/fphar.2020.00420","article-title":"Precision dosing priority criteria: Drug, disease, and patient population variables","volume":"11","author":"Tyson","year":"2020","journal-title":"Frontiers in Pharmacology"},{"issue":"2","key":"2026072314414548600_ref8","first-page":"5","article-title":"High perfomance liquid chromatography in pharmaceutical analyses","volume":"4","author":"Nikolin","year":"2004","journal-title":"Bosnian Journal of Basic Medical Sciences"},{"key":"2026072314414548600_ref9","author":"Abemaciclib"},{"issue":"03","key":"2026072314414548600_ref10","doi-asserted-by":"publisher","first-page":"128","DOI":"10.4236\/ojmc.2020.103007","article-title":"Abemaciclib, a recent novel FDA-approved small molecule inhibiting cyclin-dependant kinase 4\/6 for the treatment of metastatic breast cancer: A mini-review","volume":"10","author":"Voli","year":"2020","journal-title":"Open Journal of Medicinal Chemistry"},{"issue":"10","key":"2026072314414548600_ref11","doi-asserted-by":"publisher","first-page":"811","DOI":"10.1093\/oncolo\/oyac138","article-title":"Targeting CDK4 and 6 in cancer therapy: Emerging preclinical insights related to abemaciclib","volume":"27","author":"Wander","year":"2022","journal-title":"The Oncologist"},{"issue":"6","key":"2026072314414548600_ref12","doi-asserted-by":"publisher","first-page":"726","DOI":"10.1016\/j.jsps.2022.03.019","article-title":"Abemaciclib-loaded ethylcellulose based nanosponges for sustained cytotoxicity against MCF-7 and MDA-MB-231 human breast cancer cells lines","volume":"30","author":"Anwer","year":"2022","journal-title":"Saudi Pharmaceutical Journal"},{"issue":"1","key":"2026072314414548600_ref13","doi-asserted-by":"publisher","first-page":"e164","DOI":"10.1002\/onco.13551","article-title":"FDA approval summary: Olaparibmonotherapy or in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer","volume":"26","author":"Arora","year":"2021","journal-title":"The Oncologist"},{"key":"2026072314414548600_ref14","author":"Olaparib"},{"key":"2026072314414548600_ref15","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1016\/j.jpba.2018.01.036","article-title":"Development and validation of a high-performance liquid chromatography method for the quantitation of intracellular PARP inhibitor Olaparib in cancer cells","volume":"152","author":"Daumar","year":"2018","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"issue":"5","key":"2026072314414548600_ref16","doi-asserted-by":"publisher","first-page":"488","DOI":"10.4274\/tjps.galenos.2021.48861","article-title":"Stability indicating assay method for the quantitative determination of Olaparib in bulk and pharmaceutical dosage form","volume":"19","author":"Chaudhary","year":"2022","journal-title":"Turkish Journal of Pharmaceutical Sciences"},{"issue":"22","key":"2026072314414548600_ref17","doi-asserted-by":"publisher","first-page":"4070","DOI":"10.1002\/jssc.202200551","article-title":"Development and validation of a reversed-phase high-performance liquid chromatography\u2013ultraviolet method for abemaciclib-related substance detection in bulk drugs","volume":"45","author":"Ni","year":"2022","journal-title":"Journal of Separation Science"},{"issue":"5","key":"2026072314414548600_ref18","doi-asserted-by":"publisher","first-page":"614","DOI":"10.3390\/ph15050614","article-title":"Development and validation of a novel LC-MS\/MS method for the simultaneous determination of abemaciclib, palbociclib, ribociclib, anastrozole, letrozole, and fulvestrant in plasma samples: A prerequisite for personalized breast cancer treatment","volume":"15","author":"Turkovi\u0107","year":"2022","journal-title":"Pharmaceuticals"},{"key":"2026072314414548600_ref19","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1016\/j.jmsacl.2022.02.001","article-title":"An UHPLC-MS\/MS method for quantification of the CDK4\/6 inhibitor abemaciclib in human serum","volume":"24","author":"Habler","year":"2022","journal-title":"Journal of Mass Spectrometry and Advances in the Clinical Lab"},{"key":"2026072314414548600_ref20","doi-asserted-by":"publisher","first-page":"114225","DOI":"10.1016\/j.jpba.2021.114225","article-title":"Simultaneous quantification of abemaciclib and its active metabolites in human and mouse plasma by UHPLC\u2013MS\/MS","volume":"203","author":"Mart\u00ednez-Ch\u00e1vez","year":"2021","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"issue":"3","key":"2026072314414548600_ref21","first-page":"97","article-title":"Simple and rapid method for determination of Abemaciclib in human serum using supported liquid extraction Pretreatment and LC-MS\/MS analysis","volume":"2","author":"Sekizaki","year":"2020","journal-title":"Indonesian Journal of Pharmaceutics"},{"issue":"6","key":"2026072314414548600_ref22","first-page":"2746","article-title":"Efficient determination of Abemaciclib concentrations in human plasma via LC-MS\/MS: A rapid and reliable approach","volume":"13","author":"Sharmila","year":"2023","journal-title":"Journal of Chemical Health Risks"},{"key":"2026072314414548600_ref23","doi-asserted-by":"publisher","first-page":"116531","DOI":"10.1016\/j.jpba.2024.116531","article-title":"Assay for the quantification of abemaciclib, its metabolites, and olaparib in human plasma by liquid chromatography-tandem mass spectrometry","volume":"253","author":"Hill","year":"2025","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"key":"2026072314414548600_ref24","first-page":"05","article-title":"Validation of analytical procedures: Text and methodology. Q2 (R1)","author":"Guideline","year":"2005"},{"issue":"12","key":"2026072314414548600_ref25","doi-asserted-by":"publisher","first-page":"3866","DOI":"10.1016\/j.xphs.2021.09.001","article-title":"Degradation of polysorbate 20 by sialate O-acetylesterase in monoclonal antibody formulations","volume":"110","author":"Zhang","year":"2021","journal-title":"Journal of Pharmaceutical Sciences"},{"key":"2026072314414548600_ref26","doi-asserted-by":"publisher","first-page":"120943","DOI":"10.1016\/j.ijpharm.2021.120943","article-title":"Cannabidiol loaded extracellular vesicles sensitize triple-negative breast cancer to doxorubicin in both in-vitro and in vivo models","volume":"607","author":"Patel","year":"2021","journal-title":"International Journal of Pharmaceutics"}],"container-title":["Journal of Chromatographic Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/64\/7\/bmag022\/69881197\/bmag022.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/64\/7\/bmag022\/69881197\/bmag022.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T18:41:52Z","timestamp":1784832112000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/chromsci\/article\/doi\/10.1093\/chromsci\/bmag022\/8740665"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,23]]},"references-count":26,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7,23]]}},"URL":"https:\/\/doi.org\/10.1093\/chromsci\/bmag022","relation":{},"ISSN":["0021-9665","1945-239X"],"issn-type":[{"value":"0021-9665","type":"print"},{"value":"1945-239X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,8]]},"published":{"date-parts":[[2026,7,23]]},"article-number":"bmag022"}}