PL EN


Preferencje help
Widoczny [Schowaj] Abstrakt
Liczba wyników
Tytuł artykułu

A comparative study of HPLC and UV spectrophotometric methods for oseltamivir quantification in pharmaceutical formulations

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Oseltamivir is an antiviral drug and is used in the treatment of all influenza viruses. It is the most effective antiviral option against all influenza viruses that can infect humans. UV and LC methods have been developed and validated according to ICH guidelines for various parameters like selectivity, linearity, accuracy, precision, LOD and LOQ, robustness for the quantitative determination of oseltamivir in pharmaceutical formulations. LC method has been performed using reverse phase technique on a C-18 column with a mobile phase consisting of 20 mM potassium dihydrogen phosphate solution and acetonitrile (60:40, v/v) at 25 °C. The mobile phase flow rate was 1.2 mL min⁻¹ . For the determination of oseltamivir, UV spectrum has been recorded between 200 and 800 nm using methanol as solvent and the wavelength of 215 nm has been selected. Both methods have demonstrated good linearity, precision and recovery. No spectral and chromatographic interferences from the capsule excipients were found in UV and LC methods. In both methods, correlation coefficients were greater than 0.999 within a concentration range of 10-60 mg mL⁻¹ using UV and LC. Intra-day and inter-day precision with low relative standard deviation values were observed. The accuracy of these methods was within the range 99.85-100.17% for LC and from 99.26 to 100.70% for UV. Therefore UV and LC methods gave the most reliable outcomes for the determination of oseltamivir in pharmaceutical formulation.
Słowa kluczowe
Rocznik
Strony
258--266
Opis fizyczny
Bibliogr. 37 poz., rys., wykr.
Twórcy
  • Department of Medical Microbiology, Uşak University, School of Medicine, Uşak, Turkey
  • Department of Chemistry, Uşak University, Faculty of Health Sciences, Uşak, Turkey
  • Department of Molecular Biology and Genetics, İzmir Institute of Technology, İzmir, Turkey
  • Department of Medical Biology, Uşak University, School of Medicine, Uşak, Turkey
Bibliografia
  • 1. World Health Organization (WHO), Coronavirus Disease 2019 (COVID-19): Situation Report, April. 2021, 15.
  • 2. de Wit, E.; van Doremalen, N.; Falzarano, D.; Munster, V. J. SARS and MERS: recent insights into emerging coronaviruses. Nat. Rev. Microbiol. 2016, 14, 523–34.
  • 3. Wu, Y.; Xu, X.; Chen, Z.; Duan, J.; Hashimoto, K.; Yang, L.; Liu, C.; Yang, C. Nervous system involvement after infection with COVID-19 and other coronaviruses. Brain Behav. Immun. 2020, 87, 18–22.
  • 4. Manigandan, S.; Wu, M.-T.; Ponnusamy, V. K.; Raghavendra, V. B.; Pugazhendhi, A.; Brindhadevi, K. A systematic review on recent trends in transmission, diagnosis, prevention and imaging features of COVID-19. Process. Biochem. 2020, 98, 233–40.
  • 5. Weiss, P.; Murdoch, D. R. Clinical course and mortality risk of severe COVID-19. Lancet 2020, 395, 1014–5.
  • 6. Wu, C.; Chen, X.; Cai, Y.; Xia, J.; Zhou, X.; Xu, S.; Huang, H.; Zhang, L.; Zhou, X.; Du, C.; Zhang, Y.; Song, J.; Wang, S.; Chao, Y.; Yang, Z.; Xu, J.; Zhou, X.; Chen, D.; Xiong, W.; Xu, L.; Zhou, F.; Jiang, J.; Bai, C.; Zheng, J.; Song, Y. Risk factors associated with Acute respiratory distress Syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China. JAMA Intern. Med. 2020, 180, 934.
  • 7. Poston, J. T.; Patel, B. K.; Davis, A. M. Management of critically ill adults with COVID- 19. Am. Med. Assoc. 2020, 323(18), 1839–41.
  • 8. Onder, G.; Rezza, G.; Brusaferro, S., Case-fatality rate and characteristics of patients dying in relation to COVID-19 in Italy, JAMA. 2020, 323(18), 1775–6.
  • 9. Touret, F.; de Lamballerie, X. Of chloroquine and COVID-19. Antivir. Res. 2020, 177, 104762.
  • 10. Baden, L. R.; Rubin, E. J., Covid-19 — the search for effective therapy, N. Engl. J. Med. 2020, 382, 1851–2.
  • 11. Shen, C.; Wang, Z.; Zhao, F.; Yang, Y.; Li, J.; Yuan, J.; Wang, F.; Li, D.; Yang, M.; Xing, L.; Wei, J.; Xiao, H.; Yang, Y.; Qu, J.; Qing, L.; Chen, L.; Xu, Z.; Peng, L.; Li, Y.; Zheng, H.; Chen, F.; Huang, K.; Jiang, Y.; Liu, D.; Zhang, Z.; Liu, Y.; Liu, L. Treatment of 5 critically ill patients with COVID-19 with convalescent plasma. J. Am. Med. Assoc. 2020, 323(16), 1582–9.
  • 12. Zou, L.; Dai, L.; Zhang, X.; Zhang, Z.; Zhang, Z. Hydroxychloroquine and chloroquine: a potential and controversial treatment for COVID-19. Arch. Pharm. Res. 2020, 43, 765–72.
  • 13. Gautret, P.; Lagier, J. C.; Parola, P.; Hoang, V. T.; Meddeb, L.; Mailhe, M.; Doudier, B.; Courjon, J.; Giordanengo, V.; Vieira, V. E.; Tissot Dupont, H.; Honore, S.; Colson, P.; Chabriere, E.; La Scola, B.; Rolain, J. M.; Brouqui, P.; Raoult, D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int. J. Antimicrob. Agents 2020, 56, 105949.
  • 14. Al-Tawfiq, J. A.; Rabaan, A. A.; Hinedi, K. Influenza is more common than Middle East Respiratory Syndrome Coronavirus (MERS-CoV) among hospitalized adult Saudi patients. Trav. Med. Infect Dis. 2017, 20, 56–60. doi: 10.1016/j.tmaid.2017.10.004.
  • 15. Wang, D.; Hu, B.; Hu, C.; Zhu, F.; Liu, X.; Zhang, J.; et al. Clinical characteristics of 138 hospitalized patients with 2019 novel Coronavirus-infected pneumonia in Wuhan. China. JAMA. 2020, 323(11), 1061–9. doi: 10.1001/jama.2020.1585.
  • 16. Chiba, S. Effect of Early Oseltamivir on Outpatients without Hypoxia with Suspected COVID-19 [published online ahead of print, 2020 Dec 9]. Wien Klin Wochenschr. 2020, 1–6. doi:10.1007/s00508-020-01780-0.
  • 17. Raut, C. S.; Ghargea, D. S.; Dhabalea, P. N.; et al. Development and validation of Oseltamivir phosphate in fluvir ® by UV-spectrophotometer. J. Pharm. Technol. Res. 2010, 2, 363–6.
  • 18. Kumar, V. K.; Raju, N. A. Spectrophotometric estimation of Oseltamivir in pharmaceutical formulations. Asian J. Chem. 2009, 21, 5984–8.
  • 19. Green, M. D.; Netty, H.; Wirtz, R. A. Determination of Oseltamivir quality by colorimetric and liquid chromatographic methods. Emerg. Inf. Dis. 2008, 14, 552–6.
  • 20. Taha, E. A.; Salama, N. N.; Fattah, L., Spectrofluorimetric and spectrophotometric stability-indicating methods for determination of some oxicams using 7-chloro-4-nitrobenz-2-oxa-1,3-di-azole (NBD-CL). Chem. Pharm. Bull. 2005, 54, 653–8.
  • 21. Aydogmus, Z. Simple and sensitive spectrofluorimetric method for the determination of Oseltamivir phosphate in capsules through derivatization with fluorescamine. J. Fluoresc. 2009, 19, 673–9.
  • 22. Malipatil, S. M.; Jahan, K.; Patil, S. K. Development & validation of RP-HPLC method for the determination of Oseltamivir phos-phatein bulk drug & in dosage. Indo Glob. J Pharm Sci. 2011, 1, 57–62.
  • 23. Narasimhan, B. M.; Abida, K.; Srinivas, K. Stability indicating RP-HPLC method development and validation for Oseltamivir API. Chem. Pharm. Bull. 2008, 56, 413–7.
  • 24. ChabaihH, O. R; Guermouche, S.; et al. Rapid determination of Oseltamivir phosphate in pharmaceutical preparation using monolithic silica HPLC column. J. Liq Chromatogr. Relat. Technol. 2011, 34, 1913–24.
  • 25. Lindegardh, N.; Hien, T. T.; Singhasivanon, P.; et al. A Simple and rapid liquid chromatographic assay for evaluation of potentially counterfeit Tamiflu. J. Pharm. Biomed. Anal. 2006, 42, 430–3.
  • 26. Youssef, R. M.; Khamis, E. F.; Younis, S. E.; et al. Validated HPTLC method for the evaluation of Oseltamivir pharmaceutical formulations counterfeited with ascorbic acid compared with a colorimetric method. J. Planar Chromatogr. 2013, 5, 427–34.
  • 27. Laborde-Kummera, E.; Guadina, K.; Joseph-Charlesa, J.; et al. Development and validation of a rapid capillary electrophoresis method for the determination of Oseltamivir phosphate in Tamiflu and generic versions. J. Pharm. Biomed. Anal. 2009, 50, 544–6.
  • 28. Wiltshire, H.; Wiltshire, B.; Citron, A.; et al. Development of a High-performance liquid chromatographic-mass spectrometric assay for the specific and sensitive quantification of Ro 64-0802, an anti-influenza drug, and its pro-drug, Oseltamivir, in human and animal plasma and urine. J. Chromatogr. B. 2000, 745, 373–88.
  • 29. Heinig, K.; Buchelia, F. Sensitive determination of oseltamivir and oseltamivir carboxylate in plasma, urine, cerebrospinal fluid and brain by liquid chromatography–tandem mass spec-trometry. J. Chromatogr. B 2008, 876, 129–36.
  • 30. ICH. Q2 (R1), harmonized tripartite guideline, validation of analytical procedures: text and methodology, In Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2005.
  • 31. Center for Drug Evaluation and Research (CDER). Reviewer Guidance: Validation of Chromatographic Methods 1994.
  • 32. United State Pharmacopeia and National Formulary. The United State pharmacopeia. Rockville, MD: U.S. Pharmacopeia convention. USP 32–NF, 2009, 27, 621.
  • 33. International Conference on Harmonization (ICH), ICH Q2 Validation of Analytical Procedures: Text and Methodology International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, ICH Harmonized, Tripartite Guideline, Canada, 2005.Guideline.pdf [accessed January 12, 2020].
  • 34. AOAC International. Appendix F: Guidelines for Standard Methods Performance Requirements. AOAC Official Method of Analysis AOAC International, 2016, 1–18.
  • 35. Ahuja, S.; Dong, M. W. Handbook of Pharmaceutical Analysis by HPLC. Elsevier: The Netherlands, 2005, pp. 20–5.
  • 36. Ehmer, J.; Miller, J. H., Method Validation in Pharmaceutical Analysis: A Guide to Best Practice. Wiley-VCH: Weinheim, Germany, 2005.
  • 37. Ravisankar, P.; Navya, C. N.; Pravallika, D.; Sri, D. N. A review on step-by-step analytical method validation. IOSR J. Pharm. 2015, 5, 7–19.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-9aac8f27-02f4-4716-b174-df1bbf000653
JavaScript jest wyłączony w Twojej przeglądarce internetowej. Włącz go, a następnie odśwież stronę, aby móc w pełni z niej korzystać.