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Quality risk assessment and DoE – Practiced validated stability-indicating chromatographic method for quantification of Rivaroxaban in bulk and tablet dosage form

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A systematic DoE and Analytical Quality by Design (AQbD) approach was utilized for the development and validation of a novel stability indicating high-performance thin–layer chromatographic (HPTLC) method for Rivaroxaban (RBN) estimation in bulk and marketed formulation. A D-optimal design was used to screen the effect of solvents, volume of solvents, time from spotting to development and time for development to scanning. ANOVA results and Pareto chart revealed that toluene, methanol, water and saturation time had an impact on retention time. The critical method and material attributes were further screened by Box-Behnken design (BBD) to achieve optimal chromatographic condition. A stress degradation study was carried out and structure of major alkaline degradant was elaborated. According to the design space, a control strategy was used with toluene: methanol: water (6:2:2) and the saturation time was 15 min. A retention factor (RF) of 0.59 ± 0.05 was achieved for RBN using chromatographic plate precoated with silica gel at detection wavelength 282 nm with optimized conditions. The linear calibration curve was achieved in the concentration range of 200–1,200 ng/band with r2 > 0.998 suggesting good coordination between analyte concentration and peak areas. The quadratic model was demonstrated as the best fit model and no interaction was noted between CMAs. The optimized HPTLC method was validated critically as stated in International Conference on Harmonization (ICH) Q2 (R1) guideline and implemented successfully for stress degradation study of RBN. The developed HPTLC method obtained through AQbD application was potentially able to resolve all degradants of RBN achieved through forced degradation study. The obtained results demonstrate that a scientific AQbD approach implementation in HPTLC method development and stress degradation study drastically minimizes the number of trials in experiments, ultimately time and cost of analysis could be minimized.
Rocznik
Strony
10--20
Opis fizyczny
Bibliogr. 25 poz., tab., rys., wykr.
Twórcy
  • Department of Biochemistry, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
  • Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates
  • Center of Medical and Bio-allied Health Sciences Research, Ajman University, Ajman, P.O. Box 346, United Arab Emirates
  • Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates
  • Center of Medical and Bio-allied Health Sciences Research, Ajman University, Ajman, P.O. Box 346, United Arab Emirates
autor
  • Department of Pharmaceutical Chemistry, PES’s Modern College of Pharmacy, Sector No. 21, Yamuna Nagar, Nigdi, Pune, Maharashtra, India
  • Department of Pharmaceutics, RMD Institute of Pharmaceutical Education & Research, Pune, Maharashtra, India
  • Department of Pharmaceutics, JSPMs Rajarshi Shahu College of Pharmacy and Research, Tathawade, Pune, Maharashtra, India
  • Department of Pharmaceutical Chemistry, PES’s Modern College of Pharmacy, Sector No. 21, Yamuna Nagar, Nigdi, Pune, Maharashtra, India
Bibliografia
  • 1. Samama, M. M. The mechanism of action of rivaroxaban–an oral, direct Factor Xa inhibitor–compared with other anticoagulants. Thromb. Res. 2011, 127(6), 497–504.
  • 2. Iram, F.; Iqbal, M.; Husain, A. A review on rivaroxaban: a prominent oral anti-coagulant agent. Int. J. Pharma Chem. Res. 2015, 1, 140–8.
  • 3. Singh, A. K.; Noronha, V.; Gupta, A.; Singh, D.; Singh, P.; Singh, A.; Singh, A. Rivaroxaban: drug review. Cancer Res. Stats. Treat. 2020, 3(2), 264–9.
  • 4. Arous, B.; Al-Mardini, M. A.; Karabet, F.; Daghestani, M.; Al-Lahham, F.; Al-Askar, A. Development and validation of a liquid chromatography method for the analysis of rivaroxaban and determination of its production related impurities. Pharma. Chem. J. 2018, 52(5), 483–90.
  • 5. Reçber, T.; Haznedaroğlu, İ. C.; Çelebier, M. Review on characteristics and analytical methods of Rivaroxaban. Crit. Rev. Anal. Chem. 2020, 1–13.
  • 6. Harde, M. T.; Wankhede, S. B.; Chaudhari, P. D. A validated inherent stability indicating HPTLC method for estimation of cyclobenzaprine hydrochloride in tablets and use of MS–QTOF in characterization of its alkaline stress degradation product. Bull. Fac. Pharm.Cairo Univ. 2016, 54(2), 145–56.
  • 7. Vya, A. J.; Visana, N. M.; Patel, A. I.; Patel, A. B.; Patel, N. K.; Shah, S. R. Analytical quality by design in stress testing or stability-indicating method. Asian J. Pharm. Anal. 2021, 11(2), 170–8.
  • 8. Gp, B.; Ad, D. Development and validation of stability indicating UPLC method for the simultaneous estimation of drugs in combined dosage forms using quality by design approach. Asian J. Pharm. Anal. 2020, 10(3), 1–19.
  • 9. Das, P.; Maity, A. Analytical quality by design (AQbD): a new horizon for robust analytics in pharmaceutical process and automation. Int. J. Pharm. Drug Anal. 2017, 324–37.
  • 10. Ganorkar, A.; Gupta, K. Analytical quality by design: a mini review. Biomed. J.Sci. Tech. Res. 2017, 1(6), 1555–8.
  • 11. Krull, I.; Joseph, T.; Lukulay, P.H.; Verseput, R.; Swartz, M. A quality-by-design methodology for rapid LC method development, Part I. LCGC North Am. 2008, 26(12), 1190–7.
  • 12. Bala, C. S.; Bind, V. H.; Damayanthi, M. R.; Sireesha, A. Development and validation of UV spectrophotometric method for the determination of Rivaroxaban. Der Pharma Chem. 2013, 5, 1–5.
  • 13. Manjunatha, D. H. Determination of Rivaroxaban in pure, pharmaceutical formulations and human plasma samples by RP-HPLC. Int. J. Adv. Pharm. Anal. 2015, 5, 65–8.
  • 14. Çelebier, M.; Reçber, T.; Koçak, E.; Altinöz, S. RP-HPLC method development and validation for estimation of Rivaroxaban in pharmaceutical dosage forms. Braz. J. Pharm. Sci. 2013, 49, 359–66.
  • 15. Sarkis, N.; Bitar, Y.; Sarraj, M. M. Development and validation of RP-HPLC method for simultaneous estimation of aspirin and rivaroxaban in synthetic mixture. Res. J. Pharm. Technol. 2020, 13(11), 5459–65.
  • 16. Eswarudu, M. M.; Lalitha Devi, A.; Pallavi, K.; Srinivasa Babu, P.; Nandini Priya, S.; Sabeeha Sulthana, S. K. Novel validated RP-HPLC method for determination of rivaroxaban in bulk and its pharmaceutical dosage form. Int. J. Pharm. Sci. Rev. Res. 2020, 64(1), 183–7.
  • 17. Gouveia, F.; Bicker, J.; Santos, J.; Rocha, M.; Alves, G.; Falcão, A.; Fortuna, A. Development, validation and application of a new HPLC-DAD method for simultaneous quantification of apixaban, dabigatran, edoxaban and rivaroxaban in human plasma. J. Pharm. Biomed. Anal. 2020, 181, 113109.
  • 18. Derogis, P. B. M.; Sanches, L. R.; De Aranda, V. F.; Colombini, M. P.; Mangueira, C. L. P.; Katz, M.; Faulhaber, A. C. L.; Mendes, C. E. A.; Ferreira, C. E. D. S.; França, C. N. Determination of rivaroxaban in patient’s plasma samples by anti-Xa chromogenic test associated to High Performance Liquid Chromatography tandem Mass Spectrometry (HPLC-MS/MS). PLoS One 2017, 12(2), e0171272.
  • 19. Baldelli, S.; Cattaneo, D.; Pignatelli, P.; Perrone, V.; Pastori, D.; Radice, S.; Violi, F.; Clementi, E. Validation of an LC–MS/MS method for the simultaneous quantification of dabigatran, rivaroxaban and apixaban in human plasma. Bioanalysis 2016, 8(4), 275–83.
  • 20. Gai, S.; Huang, A.; Feng, T.; Gou, N.; Wang, X.; Lu, C.; Tang, H.; Xu, D.; Zhang, B.; Wang, L. LC–MS/MS method for simultaneous determination of Rivaroxaban and metformin in rat plasma: application to pharmacokinetic interaction study. Bioanalysis 2019, 11(24), 2269–81.
  • 21. De Oliveira, A. C.; Davanço, M. G.; De Campos, D. R.; Sanches, P. H. G.; Cirino, J. P. G.; Carvalho, P. D. O.; Antônio, M. A.; Coelho, E. C.; Porcari, A. M. Sensitive LC–MS/MS method for quantification of Rivaroxaban in plasma: application to pharmacokinetic studies. Biomed. Chromatogr. 2021, 35(9), e5147.
  • 22. Shaikh, K.; Mungantiwar, A.; Halde, S.; Pandita, N. Liquid chromatography–tandem mass spectrometry method for determination of Rivaroxaban in human plasma and its application to a pharmacokinetic study. Eur. J. Mass Spectrom. 2019, 26(2), 91–105.
  • 23. Rao, P.; Cholleti, V.; Reddy, V. Stability-indicating UPLC method for determining related substances and degradants in Rivaroxaban. Int. J. Res. Pharm. Sci. 2015, 5(2), 17–24.
  • 24. Validation of Analytical Procedures: Text and Methodology; ICH Harmonized Tripartite GuidelineS Q2 (R1): Geneva, 2005.
  • 25. Prajapati, P. B.; Bodiwala, K. B.; Shah, S. A. Analytical quality-by-design approach for the stability study of thiocolchicoside by eco-friendly chromatographic method. J. Planar Chromat. 2018, 31(6), 477–87.
Uwagi
Opracowanie rekordu ze środków MEiN, umowa nr SONP/SP/546092/2022 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2022-2023).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-f59fee46-ec3c-4f1a-8212-57133a6f6041
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