Raman Spectroscopy for the Quantitative Analysis of Solid Dosage Forms of the Active Pharmaceutical Ingredient of Febuxostat.

Gull Rimsha, Muhammad Shahbaz, Muhammad Irfan Majeed, Haq Nawaz, Nosheen Rashid, Muhammad Waseem Akram, Ifra Shabbir, Kiran Kainat, Aiman Amir, Eiman Sultan, Mulja Munir, Muhammad Imran
Author Information
  1. Gull Rimsha: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  2. Muhammad Shahbaz: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  3. Muhammad Irfan Majeed: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan. ORCID
  4. Haq Nawaz: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan. ORCID
  5. Nosheen Rashid: Department of Chemistry, University of Education, Faisalabad Campus, Faisalabad 38000, Pakistan.
  6. Muhammad Waseem Akram: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  7. Ifra Shabbir: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  8. Kiran Kainat: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  9. Aiman Amir: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  10. Eiman Sultan: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  11. Mulja Munir: Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
  12. Muhammad Imran: Department of Chemistry, Faculty of Science, King Khalid University, P.O. Box 9004, Abha 61413, Saudi Arabia.

Abstract

Raman spectroscopy has been used to characterize and quantify the solid dosage forms of the commercially available drug febuxostat. For this purpose, different formulations consisting of the febuxostat (API) and excipients with different concentrations of the API are prepared and analyzed by Raman spectroscopy to identify different spectral features related to the febuxostat API and excipients. Multivariate data analysis tools such as principal component analysis (PCA) and partial least-squares regression (PLSR) analysis are used for qualitative and quantitative analyses. PCA has been found to be useful for the qualitative monitoring of various solid dosage forms. PLSR analysis has led to the successful prediction of API concentration in the unknown samples with a sensitivity and a selectivity of 98 and 99%, respectively. Moreover, the root-mean-square error (RMSE) of calibration and validation of the PLSR model has been found to be 2.9033 and 1.35, respectively. Notably, it is found to be very helpful for the comparison between the self-made formulations of febuxostat and commercially available febuxostat tablets (40 and 80 mg) of two different brands (Gouric and Zurig). These results showed that Raman spectroscopy can be a useful and reliable technique for identifying and quantifying the active pharmaceutical ingredient (API) in commercially available solid dosage forms.

References

  1. Intern Med J. 2007 Apr;37(4):258-66 [PMID: 17388867]
  2. Spectrochim Acta A Mol Biomol Spectrosc. 2021 Jan 15;245:118900 [PMID: 32920444]
  3. Analyst. 2015 Apr 7;140(7):2482-92 [PMID: 25558476]
  4. Indian J Pharm Sci. 2013 Mar;75(2):211-6 [PMID: 24019571]
  5. Gen Psychiatr. 2022 Jan 27;35(1):e100662 [PMID: 35146334]
  6. Spectrochim Acta A Mol Biomol Spectrosc. 2020 Aug 15;237:118408 [PMID: 32371352]
  7. J Pharm Biomed Anal. 2008 Sep 10;48(1):201-4 [PMID: 18602240]
  8. Curr Med Chem. 2007;14(17):1879-86 [PMID: 17627523]
  9. J Phys Chem B. 2018 Oct 4;122(39):9218-9224 [PMID: 30208710]
  10. Technol Cancer Res Treat. 2013 Aug;12(4):371-82 [PMID: 23448574]
  11. Spectrochim Acta A Mol Biomol Spectrosc. 2017 Oct 5;185:130-138 [PMID: 28558321]
  12. Gastrointest Endosc. 2014 Jan;79(1):37-45 [PMID: 23886354]
  13. Foods. 2022 Dec 06;11(23): [PMID: 36496748]
  14. J Biol Inorg Chem. 2015 Mar;20(2):195-207 [PMID: 25501928]
  15. Curr Vasc Pharmacol. 2015;13(1):111-20 [PMID: 24837057]
  16. Pharmaceutics. 2011 Oct 14;3(4):723-30 [PMID: 24309305]
  17. Spectrochim Acta A Mol Biomol Spectrosc. 2022 Apr 5;270:120823 [PMID: 34998053]
  18. Spectrochim Acta A Mol Biomol Spectrosc. 2018 Jul 5;200:136-142 [PMID: 29677500]
  19. J Sep Sci. 2021 Jun;44(11):2177-2188 [PMID: 33773042]
  20. Ther Clin Risk Manag. 2008 Dec;4(6):1209-20 [PMID: 19337428]
  21. Spectrochim Acta A Mol Biomol Spectrosc. 2022 May 5;272:120996 [PMID: 35149485]
  22. Chem Phys Lipids. 2005 Apr;134(2):119-29 [PMID: 15784230]
  23. Microsc Res Tech. 2005 Oct;68(2):75-9 [PMID: 16228983]
  24. J Pharm Biomed Anal. 2011 Dec 5;56(4):749-57 [PMID: 21840659]
  25. Spectrochim Acta A Mol Biomol Spectrosc. 2020 Sep 5;238:118446 [PMID: 32408230]
  26. J Pharm Biomed Anal. 2014 Nov;100:329-340 [PMID: 25194347]
  27. Spectrochim Acta A Mol Biomol Spectrosc. 2001 May;57(6):1223-34 [PMID: 11419465]
  28. Spectrochim Acta A Mol Biomol Spectrosc. 2021 Mar 5;248:119188 [PMID: 33268033]
  29. J Basic Clin Pharm. 2013 Mar;4(2):36-41 [PMID: 24808668]

Word Cloud

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