x Acta Scientific | International Open Library | Open Access Journals Publishing Group

Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 4 Issue 11

Moxifloxacin as an Adjuvant Therapy in Management of COVID-19. What is Behind its Accurate Determination in Human Plasma and Pharmacokinetics Applications?

Sara AS, Eslam MS, Mohamed Raslan and Nagwa A Sabri*

Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt

*Corresponding Author: Nagwa A Sabri, Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

Received: September 05, 2020; Published: October 08, 2020

Reprints View PDF Related Articles

×

Abstract

Background: Corona virus 2019 is considered one of the most widely spreaded pandemics that significantly affected healthcare and economic development worldwide and the probability of development of a second wave of this pandemic is high. Several protocols used fluoroquinolones antibiotics, including moxifloxacin, which are one of the promising adjuvant therapy in management of Corona virus 2019 disease.

Aim: Development of a novel, sensitive and validated LC/MS/MS bio-analytical method for the determination of moxifloxacin in biological fluids and its applications in pharmacokinetics, bioequivalence studies and monitoring drug-plasma levels to assure its effectiveness in management of infections.

Methods: Protein precipitation technique was used for moxifloxacin extraction from human plasma using ciprofloxacin as an internal standard, where, human plasma samples were analyzed using the following chromatographic conditions: eluting solvent consisting of 0.5% formic acid and acetonitrile 45: 55 v/v, pumped at flow rate 0.55 ml/min, ionization mode was set on ESI positive mode, and mass to charge ratio was m/z 402à261, 332à231 for moxifloxacin and ciprofloxacin respectively. Application on bioequivalence study of moxifloxacin generic versus reference product was assessed in 24 healthy subjects, where, AUC0-t, AUC0-inf, Cmax, and Tmax. were reported.

Results: The mean recovery of moxifloxacin from human plasma was 80.108%, the lower limit of quantitation was 0.05 ug/ml and the Correlation coefficient (r2) was equal to 0.9994. Statistical analysis for the pharmacokinetic parameters using analysis of variance (ANOVA) showed a non- significant difference between generic and reference drug products.

Conclusion: The developed LC/MS/MS method proved to be simple, sensitive, selective and valid for the detection of moxifloxacin in human plasma which can be applicable in pharmacokinetic studies, therapeutic drug monitoring in different patient care settings.

Keywords: ANOVA; Corona Virus; COVID-19

×

References

  1. Hu Y., et al. “Prevalence and severity of corona virus disease 2019 (COVID-19): A systematic review and meta-analysis”. Journal of Clinical Virology 127 (2020): 104371.
  2. WHO, Coronavirus disease (COVID-19) Weekly Epidemiological Update. Data as received by WHO from national authorities, as of 10 am CEST 13 September (2020).
  3. Bulut C and Kato Y. “Epidemiology of COVID-19”. Turkish Journal of Medical Sciences 50 (2020): 563-570.
  4. Pham TDM., et al. “Quinolone antibiotics”. Medchemcomm10 (2019): 1719-1739.
  5. https://www.msdmanuals.com/professional/infectious-diseases/bacteria-and-antibacterial-drugs/fluoroquinolones
  6. Karampela I and Dalamaga M. “Could Respiratory Fluoroquinolones, Levofloxacin and Moxifloxacin, Prove to be Beneficial as an Adjunct Treatment in COVID-19?”. Archives of Medical Research (2020): S0188-4409 (20)30924-3.
  7. Sirimas Kanjanawart., et al. “Bioequivalence of 400 mg moxifloxacin tablet in healthy Thai volunteers”. Thai Journal of Pharmacology 1 (2010).
  8. Alison Brayfield (ed.), Martindale - The Complete Drug Reference, 38th ed., Pharmaceutical Press, London, UK (2014): 326.
  9. Full Prescribing Information, Avelox®, Bayer HealthCare Pharmaceuticals Inc. USA, NDA 021085, 12 Oct 10.
  10. British National Formulary (BNF) 78 September 2019 - March 2020, Chapter 5 Infection, Quinolones, (2020): 560.
  11. Tulkens PM., et al. “Moxifloxacin safety: an analysis of 14 years of clinical data”. Drugs R D2 (2012): 71-100.
  12. Scientific Discussion, Moxifloxacin (as hydrochloride) 400 mg Tablets (Macleods Pharmaceuticals Ltd), TB230, WHOPAR part 6 (2014).
  13. Scientific Discussion, Moxifloxacin (as hydrochloride) 400 mg Tablets (Hetero Labs Limited), TB 315, WHOPAR part 6, November (2017).
  14. Mamdouh R Rezk and Kamal A Badr. “Simple and rapid LC-method for determination of moxifloxacin in human plasma: A bioequivalence study in healthy volunteers”. ACAIJ 6 (2015).
  15. Public Assessment Report Scientific discussion, Moxifloxacin Pharmathen 400 mg film-coated tablets, DK/H/2218/001/DC, November (2013).
  16. Public Assessment Report, Moxifloxacin Sanovel 400 mg (film-coated tablets), DE/H/3669/001/DC, May (2013).
  17. Mӧller JG., et al. “Capillary electrophoresis with laser-induced fluorescence: a routine method to determine moxifloxacin in human body fluids in very small sample volumes”. Journal of Chromatography B: Biomedical Sciences and Applications 716 (1998): 325-334.
  18. Trindade MAG., et al. “Determination of moxifloxacin in tablets and human urine by square-wave adsorptive voltammetry”. Microchemical Journal 81 (2005): 209-216.
  19. Motwani SK., et al. “Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations”. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 68 (2007): 250-256.
  20. Ulu ST. “Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations”. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 72 (2009)138-143.
  21. , et al. “Optimization of separation and determination of moxifloxacin and its related substances by RP HPLC”. Journal of Pharmaceutical and Biomedical Analysis 50 (2009): 117-126.
  22. Hemanth Kumar AK and Ramachandran G. “Simple and rapid liquid chromatography method for determination of moxifloxacin in plasma”. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences 877 (2009): 1205-1208.
  23. Nguyen HA., et al. “Simultaneous determination of levofloxacin, gatifloxacin and moxifloxacin in serum by liquid chromatography with column switching”. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences 810 (2004): 77-83.
  24. Tatar Ulu S. “High-performance liquid chromatography assay for moxifloxacin: pharmacokinetics in human plasma”. Journal of Pharmaceutical and Biomedical Analysis 43 (2007): 320-324.
  25. Jain GK., et al. “Ultra high-pressure liquid chromatographic assay of moxifloxacin in rabbit aqueous humor after topical instillation of moxifloxacin nanoparticles”. Journal of Pharmaceutical and Biomedical Analysis 52 (2010): 110-113.
  26. K Vishwanathan., et al. “Determination of moxifloxacin in human plasma by liquid chromatography electrospray ionization tandem mass spectrometry”. Journal of Pharmaceutical and Biomedical Analysis4 (2002): 961-968.
  27. AD Pranger., et al. “Determination of moxifloxacin in human plasma, plasma ultrafltrate, and cerebrospinal fluid by a rapid and simple liquid chromatography-tandem mass spectrometry method”. Journal of Analytical Toxicology3 (2010): 135-141.
  28. Andrzej Czyrski., et al. “An HPLC Method for Determination of Moxifloxacin in Plasma and its Application in Pharmacokinetic Analysis”. Journal of Liquid Chromatography and Related Technologies1 (2017).
  29. S Tatar Ulu. “High-performance liquid chromatography assay for moxifloxacin: Pharmacokinetics in human plasma”. Journal of Pharmaceutical and Biomedical Analysis 43 (2007): 320-324.
  30. Abdelaziz AA., et al. “Validated Microbiological and HPLC Methods for the Determination of Moxifloxacin in Pharmaceutical Preparations and Human Plasma”. Brazilian Journal of Microbiology (2012): 1291-1301.
  31. Tamayo GM., et al. “Bioavailability of Two Tablet Formulations of a Single Dose of Moxifloxacin 400 mg: An Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Mexican Adult Volunteers”. Journal of Bioequivalence 6 (2014): 197-201.
  32. Arianna D Pranger., et al. “Determination of Moxifloxacin in Human Plasma, Plasma Ultrafiltrate, and Cerebrospinal Fluid by a Rapid and Simple Liquid Chromatography- Tandem Mass Spectrometry Method”. Journal of Analytical Toxicology 34 (2010).
  33. Notes on the Design of Bioequivalence Study: Moxifloxacin. WHO/PQT: medicines, Guidance Document, 02 July (2019).
  34. Guidance for Industry Bioanalytical Method Validation (2018).
  35. Guidance for Industry, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, December (2013).
  36. Wang J., et al. “Efficacy and safety of antibiotic agents in children with COVID-19: a rapid review”. Annals of Translational Medicines 10 (2020): 619.
  37. A Torres., et al. “Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia”. European Respiratory Journal1 (2003): 135-143.
  38. Dongshan YU., et al. “Treatment with Arbidol and Moxifloxacin in Ordinary and Severe Adult Patients Infected with COVID-19”. medRxiv (2020).
×

Citation

Citation: Nagwa A Sabri., et al. “Moxifloxacin as an Adjuvant Therapy in Management of COVID-19. What is Behind its Accurate Determination in Human Plasma and Pharmacokinetics Applications?". Acta Scientific Pharmaceutical Sciences 4.11 (2020): 30-37.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is November 25, 2024.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of "Best Article of the Issue"
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.

Contact US





Creative Commons License Open Access by Acta Scientific is licensed under a Creative Commons Attribution 4.0 International License
Based on a work at https://actascientific.com

ff

Acta-Publications

ff

© 2021 Acta Scientific, All rights reserved.