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Vol. 36 No. 1 (2024): Vol 36 Issue 1, 2024

Copyright (c) 2023 DURGA PRASAD BEDA, Vijay Nayak Bhukya

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Characterization of Prasugrel Degradation Profile by Several Oxidative Reagents using HPLC and LC-MS/MS Technique

https://doi.org/10.14233/ajchem.2024.30710
Vijay Nayak Bhukya
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Hyderabad-502329, India
https://orcid.org/0000-0002-7023-4553
Durga Prasad Beda
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Hyderabad-502329, India
https://orcid.org/0000-0002-8135-3291

Corresponding Author(s) : Durga Prasad Beda

dbeda@gitam.edu

Asian Journal of Chemistry, Vol. 36 No. 1 (2024): Vol 36 Issue 1, 2024

Abstract

Prasugrel, a derivative of thienopyridine functions as a prodrug that exerts irreversible inhibition on platelet ADP receptors by  specifically targeting the P2Y12 receptor. In pharmaceuticals, the stability of the product plays a crucial role in establishing the shelf life of product. The second common degradation pathway next to hydrolysis is the oxidation. In practice, the oxidative stress studies were carried out using hydrogen peroxide (H2O2), free radicals, oxygen purging, transition metals, singlet oxygen, Fenton reagent, etc. This study compares the oxidative degradation behaviour of prasugrel hydrochloride using different oxidative stressors and was analyzed by HPLC using a method that could separate degradation products individually and from the drug. The degradation products formed under different stress conditions were characterized using LC-TOF-MS/MS. Analysis of accelerated stability samples of prasugrel formulation revealed that the degradation products formed under azobisisobutyronitrile (AIBN) and H2O2 stress conditions were simulated with the stability data. This study on prasugrel showed that the degradation products formed with H2O2 were also observed under hydrolytic conditions. In the pharmaceutical industry, H2O2 is the only oxidative stressor (< 95%) used to study the oxidation degradation of the sample. The present work has demonstrated that AIBN serves as a valuable oxidative stressor for accurately assessing the oxidative stability of drug.

Keywords

Degradation products Prasugrel hydrochloride Oxidative stressors Azobisisobutyronitrile
Bhukya, V. N., & Beda, D. P. (2023). Characterization of Prasugrel Degradation Profile by Several Oxidative Reagents using HPLC and LC-MS/MS Technique. Asian Journal of Chemistry, 36(1), 148–160. https://doi.org/10.14233/ajchem.2024.30710
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References
  1. S.D. Wiviott, E.M. Antman and E. Braunwald, Circulation, 122, 394 (2010); https://doi.org/10.1161/CIRCULATIONAHA.109.921502
  2. D.J. Angiolillo, S. Suryadevara, P. Capranzano and T.A. Bass, Expert Opin. Pharmacother., 9, 2893 (2008); https://doi.org/10.1517/14656566.9.16.2893
  3. S. Yoshioka and V.J. Stella, Stability of Drugs and Dosage Forms, Springer: New York, NY (2002).
  4. M. Remko, A. Remková and R. Broer, Int. J. Mol. Sci., 17, 388 (2016); https://doi.org/10.3390/ijms17030388
  5. K.K. Hotha, S. Roychowdhury and V. Subramanian, Am. J. Anal. Chem., 7, 107 (2016); https://doi.org/10.4236/ajac.2016.71011
  6. A.L. Freed, H.E. Strohmeyer, M. Mahjour, V. Sadineni, D.L. Reid and C.A. Kingsmill, Int. J. Pharm., 357, 180 (2008); https://doi.org/10.1016/j.ijpharm.2008.01.061
  7. K.C. Waterman, R.C. Adami, K.M. Alsante, J. Hong, M.S. Landis, F. Lombardo and C.J. Roberts, Pharm. Dev. Technol., 7, 1 (2002); https://doi.org/10.1081/PDT-120002237
  8. M.-A. Del Barrio, J. Hu, P. Zhou and N. Cauchon, J. Pharm. Biomed. Anal., 41, 738 (2006); https://doi.org/10.1016/j.jpba.2005.12.033
  9. A. Gabriè, •. Hodnik and S. Pajk, Pharmaceutics, 14, 325 (2022); https://doi.org/10.3390/pharmaceutics14020325
  10. S.W. Hovorka and C. Schöneich, J. Pharm. Sci., 90, 253 (2001); https://doi.org/10.1002/1520-6017(200103)90:3<253::AIDJPS1>3.0.CO;2-W
  11. G. Boccardi, Farmaco, 49, 431 (1994).
  12. P.A. Harmon, K. Kosuda, E. Nelson, M. Mowery and R.A. Reed, J. Pharm. Sci., 95, 2014 (2006); https://doi.org/10.1002/jps.20668
  13. ICH Topic Q1 A (R2), Stability Testing of New Drug Substances and Products.; ICH Harmonised Tripartite Guideline (2003).
  14. E. Tamizi and A. Jouyban, Eur. J. Pharm. Biopharm., 98, 26 (2016); https://doi.org/10.1016/j.ejpb.2015.10.016
  15. K. Sahu, C. Karthikeyan, N.S.H.N. Moorthy and P. Trivedi, J. Liq. Chromatogr. Relat. Technol., 34, 1870 (2011); https://doi.org/10.1080/10826076.2011.582209
  16. A.A. Sakur, D. Nashed, M. Haroun and I. Noureldin, Res. J. Pharm. Technol., 11, 631 (2018); https://doi.org/10.5958/0974-360X.2018.00118.X
  17. S.A. Kumar, J.V.L.N.S. Rao, K. Jhansi Rani, S.S.S. Jaya Madhuri and T.S.R.K.V. Prasad, Int. Res. J. Pharm., 4, 254 (2013); https://doi.org/10.7897/2230-8407.04355
  18. S. Arar, K. Sweidan and S. Qasem, J. Liq. Chromatogr. Rel. Technol., 41, 14 (2018); https://doi.org/10.1080/10826076.2017.1409238
  19. V. Malati, A. Raghupatireddy, K. Mukkanti and M.V. Suryanarayana, J. Liq. Chromatogr. Rel. Technol., 36, 61 (2012); https://doi.org/10.1080/10826076.2011.644052
  20. B.S. Prasad and S. Jayakumari, Asian J. Pharm. Clin. Res., 12, 1 (2019); https://doi.org/10.22159/ajpcr.2019.v12i4.29954
  21. N.S. Gadhari, S.S. Patil, J.V. Gholave, A.V. Pansare, V.R. Patil and S.S. Upadhyay, Curr. Chromatogr., 9, e170122200262 (2022); https://doi.org/10.2174/2213240609666220117101725
  22. S. Patel, C. Patel and V. Patel, Indian J. Pharm. Sci., 75, 413 (2013); https://doi.org/10.4103/0250-474X.119816
  23. V.K. Ahirrao and L.C. Stability-Indicating, Sci. Pharm., 80, 379 (2012); https://doi.org/10.3797/scipharm.1201-05
  24. D. Birket, Eng. Technol., 13, 65 (2018); https://doi.org/10.1049/et.2018.0325
  25. S.W. Baertschi, L. Maxwell-Backer, M. Clemens, T.A. Smitka, J.R. Draper, K.W. Taylor, A. Kaerner and P.J. Jansen, J. Pharm. Sci., 108, 2842 (2019); https://doi.org/10.1016/j.xphs.2019.04.008
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