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Vol. 35 No. 7 (2023): Vol 35 Issue 7 (2023)

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A Validated Liquid Chromatographic Method for the Estimation of Imatinib Mesylate in Dosage Forms: Application to Chemometrics based Robustness Testing and Greenness Assessment

https://doi.org/10.14233/ajchem.2023.27595
S.S. Panda
Department of Pharmaceutical Analysis & Quality Assurance, Roland Institute of Pharmaceutical Sciences, Berhampur-760010, India
https://orcid.org/0000-0002-9138-5561
S.K. Mohanty
Department of Pharmaceutical Analysis & Quality Assurance, Roland Institute of Pharmaceutical Sciences, Berhampur-760010, India
V.S. Pulusu
Department of Chemistry & Biochemistry, Ohio University, Athens, Ohio, USA
https://orcid.org/0000-0003-1801-6388
S. Sahu
Department of Pharmaceutical Chemistry, Dadhichi College of Pharmacy, Cuttack-754002, India
https://orcid.org/0009-0005-6528-9807
B. Das
Department of Pharmaceutical Analysis, Anwarul Uloom College of Pharmacy, Hyderabad-500001, India
https://orcid.org/0009-0003-7493-7189

Corresponding Author(s) : S.S. Panda

sagarguddu2002@gmail.com

Asian Journal of Chemistry, Vol. 35 No. 7 (2023): Vol 35 Issue 7 (2023)

Abstract

An eco-friendly liquid chromatography method was developed for determining imatinib mesylate in pharmaceuticals. During pre-development studies, Using a greener mobile phase and a combination of qualitative and semi-quantitative green metrics techniques, the environmental sustainability of the procedure was maintained. Methanol:water (pH maintained at 3.5 using orthophosphoric acid) at 75:25%, v/v flowing at 1 mL/min was the final mobile phase used on a C-18 column. The diode array detector detected imatinib at 262 nm. Method specificity, accuracy, precision, selectivity and system suitability were tested over a linear concentration range of 5-120 μg/mL of imatinib. The limit of detection and limit of quantitation values were 1.5 and 5.0 μg/mL, respectively. In addition, the factorial design showed the procedure to be reliable with minimum testing. Finally, the method recovered the maximum (> 99%) of the analyte from the dosage form. Overall, the present method is suitable for routine applications in quality control of dosage forms of imatinib.

Keywords

Analytical eco-scale Imatinib mesylate Liquid chromatography Robustness Taguchi design
Panda, S., Mohanty, S., Pulusu, V., Sahu, S., & Das, B. (2023). A Validated Liquid Chromatographic Method for the Estimation of Imatinib Mesylate in Dosage Forms: Application to Chemometrics based Robustness Testing and Greenness Assessment. Asian Journal of Chemistry, 35(7), 1727–1733. https://doi.org/10.14233/ajchem.2023.27595
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References
  1. M.M. da Rocha, L. Otero, T.F. Padilha, J. Dobbin, C. de Souza-Fernandez, E. Abdelhay and T. de Souza Fernandez, Blood Cancer J., 1, e45 (2011); https://doi.org/10.1038/bcj.2011.45
  2. S.A. Cross and K.A. Lyseng-Williamson, Drugs, 67, 2645 (2007); https://doi.org/10.2165/00003495-200767170-00013
  3. L.F. Lopes and C.E. Bacchi, J. Cell. Mol. Med., 14, 42 (2010); https://doi.org/10.1111/j.1582-4934.2009.00983.x
  4. C. Kovitz, H. Kantarjian, G. Garcia-Manero, L.V. Abruzzo and J. Cortes, Blood, 108, 2811 (2006); https://doi.org/10.1182/blood-2006-04-017400
  5. G. Helbig, Expert Rev. Clin. Immunol., 14, 163 (2018); https://doi.org/10.1080/1744666X.2018.1425142
  6. E. Barozzi, C. Bucelli, F.I. Grifoni, U. Gianelli, A. Iurlo and D. Cattaneo, Front. Oncol., 11, 819097 (2022); https://doi.org/10.3389/fonc.2021.819097
  7. S.C. Sweetman, Martindale: The Complete Drug Reference, Pharmaceutical Press, London, p. 807 (2014).
  8. G. Bende, S. Kollipara, V. Sekar and R. Saha, Pharmazie, 63, 641 (2008).
  9. S.J. Patil, R.C. Doijad and P.P. Dhumal, Asian J. Pharm. Clin. Res., 6, 54 (2013).
  10. E.B. Atici and B. Karliga, J. Pharm. Biomed. Anal., 114, 330 (2015); https://doi.org/10.1016/j.jpba.2015.06.011
  11. J. Li, Y. Huang, L. Huang, L. Ye, Z. Zhou, G. Xiang and L. Xu, J. Pharm. Biomed. Anal., 70, 26 (2012); https://doi.org/10.1016/j.jpba.2012.05.010
  12. K. Ramakrishna, N.V.V.S.S. Raman, K.M.V.N. Rao, A.V.S.S. Prasad and K.S. Reddy, J. Pharm. Biomed. Anal., 46, 780 (2008); https://doi.org/10.1016/j.jpba.2007.11.013
  13. Y. Zhang, S. Qiang, Z. Yu, W. Zhang, Z. Xu, L. Yang, A. Wen and T. Hang, J. Chromatogr. Sci., 52, 344 (2014); https://doi.org/10.1093/chromsci/bmt037
  14. V. Iacuzzi, B. Posocco, M. Zanchetta, M. Montico, E. Marangon, A.S. Poetto, M. Buzzo, S. Gagno, A. Buonadonna, M. Guardascione, B. Casetta and G. Toffoli, PLoS One, 14, e0225225 (2019); https://doi.org/10.1371/journal.pone.0225225
  15. J. Roosendaal, N. Venekamp, L. Lucas, H. Rosing and J.H. Beijnen, Pharmazie, 75, 136 (2020); https://doi.org/10.1691/ph.2020.9150
  16. M.A. Rosasco, M.A. Moyano, M.T. Pizzorno and A.I. Segall, J. Liq. Chromatogr. Rel. Technol., 28, 3283 (2005); https://doi.org/10.1080/10826070500330976
  17. P. Sandhya, P.V. Priya, N.A. Shyamala Devi and J.V.C. Sharma, World J. Pharm. Pharm. Sci., 3, 682 (2013).
  18. L.M. Negi, M. Jagg and S. Talegaonkar, J. Adv. Pharm. Educ. Res., 3, 238 (2013).
  19. P. Shah, N. Shah and R. Shah, Int. J. Pharm. Sci. Res., 6, 4453 (2015); https://doi.org/10.13040/IJPSR.0975-8232.6(10).4453-68
  20. P. Ravisankar, A. Niharika, K.A. Rani, S.M. Neeha and G. Pavan, Der Pharm. Lett., 7, 102 (2015).
  21. P. Shah and R. Shah, Int. J. Pharm. Tech. Res., 8, 128 (2015).
  22. F. Hasin, M.I. Islam, M.F. Ahmad and M.M.H. Rakib, Eur. J. Biomed. Pharm. Sci., 4, 74 (2017).
  23. A.K. Kuna, G. Seru and G.V. Radha, Asian J. Pharm. Clin. Res., 11, 136 (2018); https://doi.org/10.22159/ajpcr.2018.v11i3.21073
  24. H.A. Alhazmi, D.A. Moraya, E. Alahdal, M. Kariri, M. Al Bratty, Z. Rehman and S.A. Javed, Trop. J. Pharm. Res., 17, 1127 (2018); https://doi.org/10.4314/tjpr.v17i6.20
  25. R.V. Rele and S.P. Patil, Asian J. Res. Chem., 12, 79 (2019); https://doi.org/10.5958/0974-4150.2019.00018.X
  26. P. Venkateshwarlu and M.M. Patel, J. Pharm. Res. Int., 33, 330 (2021); https://doi.org/10.9734/jpri/2021/v33i62A35541
  27. S.B. Ganorkar and A.A. Shirkhedkar, Rev. Anal. Chem., 36, 1 (2017); https://doi.org/10.1515/revac-2016-0025
  28. R.N. Dash, H. Mohammed and T. Humaira, Saudi Pharm. J., 24, 92 (2016); https://doi.org/10.1016/j.jsps.2015.03.004
  29. L.H. Keith, L.U. Gron and J.L. Young, Chem. Rev., 107, 2695 (2007); https://doi.org/10.1021/cr068359e
  30. J. Plotka, M. Tobiszewski, A.M. Sulej, M. Kupska, T. Górecki and J. Namiesnik, J. Chromatogr. A, 1307, 1 (2013); https://doi.org/10.1016/j.chroma.2013.07.099
  31. A. Galuszka, Z. Migaszewski and J. Namieœnik, Trends Analyt. Chem., 50, 78 (2013); https://doi.org/10.1016/j.trac.2013.04.010
  32. K. Van Aken, L. Strekowski and L. Patiny, Beilstein J. Org. Chem., 2, 1 (2006); https://doi.org/10.1186/1860-5397-2-3
  33. A. Galuszka, Z.M. Migaszewski, P. Konieczka and J. Namiesnik, Trends Analyt. Chem., 37, 61 (2012); https://doi.org/10.1016/j.trac.2012.03.013
  34. N.S. Rashed, S. Zayed, A. Abdelazeem and F. Fouad, Microchem. J., 157, 105069 (2020); https://doi.org/10.1016/j.microc.2020.105069
  35. ICH Expert Working Group, ICH Harmonized Tripartite Guideline-Validation of Analytical Procedures Text and Methodology: Q2(R1), In Geneva: International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (2005).
  36. Y. van der Heyden, M. Jimidar, N. Niemeijer, J. Smeyers-Verbeke, E. Hund, R. Peeters, J. Massart and J. Hoogmartens, J. Chromatogr. A, 845, 145 (1999); https://doi.org/10.1016/S0021-9673(99)00328-3
  37. C.J. Welch, N.Wu, M. Biba, R. Hartman, T. Brkovic, X. Gong, R. Helmy, W. Schafer, J. Cuff, Z. Pirzada and L. Zhou, Trends Analyt. Chem., 29, 667 (2010); https://doi.org/10.1016/j.trac.2010.03.008
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