120
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Simultaneous Determination of Duloxetine and 4-Hydroxy Duloxetine Glucuronide in Human Plasma and Back-Conversion Study

ORCID Icon, , ORCID Icon, , , , & ORCID Icon show all
Pages 1681-1696 | Received 31 Aug 2021, Accepted 14 Oct 2021, Published online: 08 Nov 2021

References

  • Marydele JO . The Merck Index: an encyclopedia of chemicals, drugs, and biologicals. 14th ed. Whitehouse StationMerck and Co. Inc, NJ, USA (2006).
  • Chalon SA , GranierLA, VandenhendeFRet al. Duloxetine increases serotonin and norepinephrine availability in healthy subjects: a double-blind, controlled study. Neuropsychopharmacology28, 1685–1693 (2003).
  • Stahl M , Lee-ZimmermanC, CartwrightS, AnnMorrissette D. Serotonergic drugs for depression and beyond. Curr. Drug Targets14, 578–585 (2013).
  • Bandelow B , SherL, BuneviciusRet al. Guidelines for the pharmacological treatment of anxiety disorders, obsessive-compulsive disorder and posttraumatic stress disorder in primary care. Int. J. Psychiatry. Clin. Pract.16, 77–84 (2013).
  • Moser P . xPharm: The Comprehensive Pharmacology Reference.Elsevier (2008).
  • Sharma A , GoldbergMJ, CerimeleBJ. Pharmacokinetics and safety of duloxetine, a dual-serotonin and norepinephrine reuptake inhibitor. J. Clin. Pharmacol.40, 161–167 (2000).
  • Dhillion S . Duloxetine: a review of its use in the management of major depressive disorder in older adults. Drugs Aging30, 59–79 (2013).
  • Kaza M , GilantE, FilistM, SzlaskaI, PawińskiP, RudzkiPJ. Determination of duloxetine in human plasma with proven lack of influence of the major metabolite 4-hydroxyduloxetine. Clin. Biochem.47, 1313–1315 (2014).
  • Satonin DK , McCullochJD, KuoFJ, KnadlerMP. Development and validation of a liquid chromatography-tandem mass spectrometric method for the determination of the major metabolites of duloxetine in human plasma. J. Chromatogr. B Biomed. Appl. Technol. Biomed. Life Sci.852, 582–589 (2007).
  • Lantz RJ , GillespieTA, RashTJet al. Metabolism, excretion, and pharmacokinetics of duloxetine in healthy human subjects. Drug Metab. Dispos.31, 1142–1150 (2003).
  • European Medicines Agency, Guideline on bioanalytical method validation, in: Committee for Medicinal Products for Human Use (2012). https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
  • International Conference on Harmonization . Guideline M10 on bioanalytical method validation (step 2b) (2019). https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m10-bioanalytical-method-validation-step-2b_en.pdf
  • Mercolini L , MandrioliR, CazzollaR, AmoreM, RaggiMA. HPLC analysis of the novel antidepressant duloxetine in human plasma after an original solid-phase extraction procedure. J. Chromatogr. B Biomed. Appl. Technol. Biomed. Life Sci.856, 81–87 (2007).
  • Suh JH , LeeYY, LeeHJet al. Dispersive liquid-liquid microextraction based on solidification of floating organic droplets followed by high performance liquid chromatography for the determination of duloxetine in human plasma. J. Pharm. Biomed. Anal.75, 214–219 (2013).
  • Li HF , LiT, LiY, ShenYF. Pharmacokinetics and safety of duloxetine enteric-coated tablets in Chinese healthy volunteers: a randomized, open-label, single- and multiple-dose study. Clinc. Psychopharmacol. Neurosci.11, 28–33 (2013).
  • Ma N , ZhangBK, LiHDet al. Determination of duloxetine in human plasma via LC/MS and subsequent application to a pharmacokinetic study in healthy Chinese volunteers. Clin. Chim. Acta380, 100–105 (2007).
  • Selvan PS , GowdaKV, MandalU, SolomonWDS, PalTK. Determination of duloxetine in human plasma by liquid chromatography with atmospheric pressure ionization-tandem mass spectrometry and its application to pharmacokinetic study. J. Chromatogr. B Biomed. Appl. Technol. Biomed. Life Sci.858, 269–275 (2007).
  • Gajula R , MaddelaR, RaviVB, InamaduguJK, PilliNR. A rapid and sensitive liquid chromatography-tandem mass spectrometric assay for duloxetine in human plasma: its pharmacokinetic application. J. Pharm. Anal.3, 36–44 (2013).
  • Techatanawat I , BhuketPRN, TeerawongananPet al. Bioequivalence study of duloxetine hydrochloride 60 mg EC capsules in the fasting and fed states in healthy Thai male volunteers. J. Health Res.29, 165–169 (2015).
  • Chen XJ , LiangC, CuiLJet al. A rapid LC-MS/MS method for simultaneous determination of quetiapine and duloxetine in rat plasma and its application to pharmacokinetic interaction study. J. Food Drug Anal.27, 323–331 (2019).
  • Rizea-Savu S , DunaSN, GhitaA, LordachescuA, ChirilaM. The effect of food on the single-dose bioavailability and tolerability of the highest marketed strength of duloxetine. Clin. Pharmacol. Drug Dev.9, 797–804 (2020).
  • Al-Shalabi R , HefnawyM, AlrabiahHet al. Validated microemulsion liquid chromatography-fluorescence method for the quantification of duloxetine and its two main metabolites in plasma: application to clinical pharmacokinetic studies. Curr. Pharm. Anal.15, 399–411 (2019).
  • Briscoe C , StilesMR, HageDS. System suitability in bioanalytical LC/MS/MS. J. Pharm. Biomed. Anal.44, 484–491 (2007).
  • Loh GOK , WongEYL, TanYTFet al. Simple and rapid LC-MS/MS method for determination of sitagliptin in human plasma and application to bioequivalence study. J. Chromatogr. B Biomed. Appl. Technol. Biomed. Life Sci.1159, 122337 (2020).
  • Food and Drug Administration, Guidance for Industry: Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food Drug Adm Cent Drug Eval Res (CDER), Cent Vet Met (2018). https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
  • Algete P , KancherlaP, BoodidaS, AlbaseerSS. A fast and reliable LC-MS/MS method for simultaneous quantitation of fluoxetine and mirtazapine in human plasma. Anal. Methods18, 7407–7414 (2014).
  • Banerjee S , MazumdarS. Electrospray ionization mass spectrometry: a technique to access the information beyond the molecular weight of the analyte. Int. J. Anal. Chem.2012, 1–40 (2012).
  • Crowley TE . High-performance liquid chromatography (Chapter 5). In: Purification and Characterization of Secondary Metabolites.Academic Press (2020).
  • Radel RJ , SullivanJM, HatfieldJD. Catalytic oxidation of hydroquinone to quinone using molecular oxygen. Ind. Eng. Chem. Prod. Res. Dev.21, 566–570 (1982).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.