A Highly Sensitive Nonextraction-Assisted HPLC Method with Fluorescence Detection for Quantification of Duvelisib in Plasma Samples and its Application to Pharmacokinetic Study in Rats

References

• Canadian Cancer Society. Chronic lymphocytic leukemia. Ontario; 2019. Available from: http://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/chronic-lymphocytic-leukemia/?region=on. Accessed 44, 2021.
   Google Scholar
• The American Chemical Society. Key statistics for chronic lymphocytic leukemia. Washington; 2019. Available from: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/key-statistics.html. Accessed 610, 2021.
   Google Scholar
• KotiahSD. Chronic lymphocytic leukemia treatment protocols. New York; 2019. Available from: https://emedicine.medscape.com/article/2005390-overview. Accessed 44, 2021.
   Google Scholar
• BelloC, ZhangL, NaghashpourM. Follicular lymphoma: current management and future directions. Cancer Control. 2012;19(3):187–195. doi:10.1177/10732748120190030322710894
   PubMed Web of Science ®Google Scholar
• ClaytonE, BardiG, BellSE, et al. A crucial role for the p110 delta subunit of phosphatidylinositol 3-kinase in B cell development and activation. J Exp Med. 2002;196(6):753–763. doi:10.1084/jem.2002080512235209
   PubMed Web of Science ®Google Scholar
• Fung-LeungWP. Phosphoinositide 3-kinase delta (PI3Kδ) in leukocyte signaling and function. Cell Signal. 2011;23(4):603–608. doi:10.1016/j.cellsig.2010.10.00220940048
   PubMed Web of Science ®Google Scholar
• PelusoM, FaiaK, WinklerD, et al. Duvelisib (IPI-145) inhibits malignant B-cell proliferation and disrupts signaling from the tumor microenvironment through mechanisms that are dependent on PI3K-δ and PI3K-γ. Blood. 2014;124(21):328. doi:10.1182/blood.V124.21.328.32824894774
   PubMed Web of Science ®Google Scholar
• HoellenriegelJ, MeadowsSA, SivinaM, et al. The phosphoinositide 30-kinase delta inhibitor, CAL-101, inhibits B-cell receptor signaling and chemokine networks in chronic lymphocytic leukemia. Blood. 2011;118(13):3603–3612. doi:10.1182/blood-2011-05-35249221803855
   PubMed Web of Science ®Google Scholar
• OkkenhaugK, BilancioA, FarjotG, et al. Impaired B and T cell antigen receptor signaling in p110 delta PI 3-kinase mutant mice. Science. 2002;297(5583):1031–1034. doi:10.1126/science.107356012130661
   PubMed Web of Science ®Google Scholar
• VanhaesebroeckB, Guillermet-GuibertJ, GrauperaM, BilangesB. The emerging mechanisms of isoform-specific PI3K signalling. Nat Rev Mol Cell Biol. 2010;11(5):329–341.20379207
   PubMed Web of Science ®Google Scholar
• FaiaK, WhiteK, ProctorJ, et al. The phosphoinositide-3 kinase (PI3K)-δ,γ inhibitor, duvelisib shows preclinical synergy with multiple targeted therapies in hematologic malignancies. PLoS One. 2018;13(8):1–14. doi:10.1371/journal.pone.0200725
   Web of Science ®Google Scholar
• QingshanY, PrexyM, TerryN, ChristopheQ, VarshaG. Idelalisib: first-in-class PI3K delta inhibitor for the treatment of chronic lymphocytic leukemia, small lymphocytic leukemia, and follicular lymphoma. Clin Cancer Res. 2015;21(7):1537–1542. doi:10.1158/1078-0432.CCR-14-203425670221
   PubMed Web of Science ®Google Scholar
• BalakrishnanK, PelusoM, FuM, et al. The phosphoinositide-3-kinase (PI3K)-delta and gamma inhibitor, IPI-145 (Duvelisib), overcomes signals from the PI3K/AKT/S6 pathway and promotes apoptosis in CLL. Leukemia. 2015;29(9):1811–1822. doi:10.1038/leu.2015.10525917267
   PubMed Web of Science ®Google Scholar
• U.S. Food & Drug Administration (FDA). Duvelisib (Copiktra, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Maryland; 2018. Available from: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm621503.htm. Accessed 44, 2021.
   Google Scholar
• LeahL. Duvelisib granted priority review for R/R CLL/SLL and FL. Cancer Network; 2018. Available from: https://www.cancernetwork.com/view/duvelisib-granted-priority-review-rr-cllsll-and-fl. Accessed 522, 2021.
   Google Scholar
• ChS, AnnapurnaP, NatarajKS, PawarKMA. Analytical quality by design approach in RP-HPLC method development and validation for the estimation of duvelisib. Asian J Pharm Clin Res. 2021;14(2):99–108. doi:10.22159/ajpcr.2021.v14i2.40181
   Google Scholar
• SiddeshA, SriramD, ZakkulaA, et al. Validated HPLC‐UV method for simultaneous quantification of phosphatidylinositol 3‐kinase inhibitors, copanlisib, duvelisib and idelalisib, in rat plasma: application to a pharmacokinetic study in rats. Biomed Chromtogr. 2020;35(4):e5015.
   Web of Science ®Google Scholar
• NigadePB, GunduJ, PaiKS, NemmaniKVS. Prediction of tissue-to-plasma ratios of basic compounds in mice. Eur J Drug Metab Pharmacokinet. 2017;42(5):835–847. doi:10.1007/s13318-017-0402-528194579
   PubMed Web of Science ®Google Scholar
• ShaoY, XieS, ZhuH, DuX, XuR. Development of a novel and quick LCMS/MS method for the pharmacokinetic analysis of duvelisib in beagle dogs. J Pharm Biomed Anal. 2020;187:113355. doi:10.1016/j.jpba.2020.11335532442869
   PubMed Web of Science ®Google Scholar
• The International Conference on Harmonization (ICH). Q2(R1): Validation of Analytical Procedure: Text and Methodology. Geneva: The International Conference on Harmonization (ICH); 2005.
   Google Scholar
• HorwitzSM, KochR, PorcuP, et al. Activity of the PI3K-δ,γ inhibitor duvelisib in a Phase 1 trial and preclinical models of T-cell lymphoma. Blood. 2018;131(8):888–898. doi:10.1182/blood-2017-08-80247029233821
   PubMed Web of Science ®Google Scholar
• BlairHA. Duvelisib: first global approval. Drugs. 2018;78(17):1847–1853. doi:10.1007/s40265-018-1013-430430368
   PubMed Web of Science ®Google Scholar
• FlinnIW, PatelM, OkiY, et al. Duvelisib, an oral dual PI3K-δ, γ inhibitor, shows clinical activity in indolent non-Hodgkin lymphoma in a phase 1 study. Am J Hematol. 2018;93(11):1311–1317. doi:10.1002/ajh.2522830033575
   PubMed Web of Science ®Google Scholar
• DarwishIA, MahmoudAM, KhalilNY. Nonextractive procedure and precolumn derivatization with 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole for trace determination of trimetazidine in plasma by high-performance liquid chromatography with fluorescence detection. J AOAC Int. 2008;91(5):1037–1044. doi:10.1093/jaoac/91.5.103718980116
   PubMed Web of Science ®Google Scholar
• DarwishIA, Al-MajedAA, MahmoudAM, KhalilNY. New nonextractive and highly sensitive high-performance liquid chromatographic method for determination of paroxetine in plasma after offline precolumn derivatization with 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole. J AOAC Int. 2009;92(5):1349–1355. doi:10.1093/jaoac/92.5.134919916372
   PubMed Web of Science ®Google Scholar
• KhalilNY, MahmoudAM, DarwishIA, Al-MajedAA. Highly sensitive HPLC method with automated co-sense system and fluorescence detection for determination of sertraline in human plasma. Chromatographia. 2010;71(9–10):825–831. doi:10.1365/s10337-010-1560-7
   Web of Science ®Google Scholar
• BlaisEM, RawlsKD, DoughertyBV, et al. Reconciled rat and human metabolic networks for comparative toxicogenomics and biomarker predictions. Nat Commun. 2017;8:14250. doi:10.1038/ncomms1425028176778
   PubMed Web of Science ®Google Scholar
• AlmomenA, MaherHM, AlzomanNZ, ShehataSM, AlsubaieA. Flavoured water consumption alters pharmacokinetic parameters and increases exposure of erlotinib and gefitinib in a preclinical study using Wistar rats. Peer J. 2020;8:e9881.33024629
   PubMed Web of Science ®Google Scholar