Using Design Space and Response Surface Methodology for developing a liquid chromatography method for simultaneous determination of five statins in pharmaceutical form

• Autorzy: Belmir H. , Abourriche A. , Bennamara A. , Saffaj T. , Ihssane Bouchaib

Identyfikatory

DOI

10.1556/1326.2020.00849

• Języki publikacji: EN

Abstrakty

EN

This study describes the development of a method allowing the simultaneous separation and quantification of five statins by High performance liquid chromatography/Diode Array Detector (HPLC/ DAD). Optimization was accomplished using chemometric tools such as the Design Space (DS) and Response Surface Methodology (RSM). Central Composite Design (CCD) and DS were applied for the optimization of the chromatographic procedure as well as the robustness of the chromatographic method by taking the ratio of the percentage of acetonitrile (%ACN) Buffer solution, the pH and the mobile phase flow rate as critical parameters. Satisfactory results were obtained after the optimization phase with a percentage of mobile phase equal to 46.19%, a pH of 4.16 and the flow rate is 1.4 mL min1 by setting the resolution limits above 6, and the target retention time of 20 min. Using the DS and CCD approach, we have developed a robust and reliable procedure for the simultaneous and accurate separation and quantification of the five statins.

Słowa kluczowe

EN

statins; HPLC-DAD; design space; central composite design; Plackett–Burman design

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2021
• Tom: Vol. 33, no. 4
• Strony: 345--353
• Opis fizyczny: Bibliogr. 26 poz., rys., tab.

Twórcy

autor

Belmir H.

• Laboratory Biomolecules and Organic Synthesis, Hassan 2 University, Casablanca, Morocco
• Laboratory of Applied Organic Chemistry, Sidi Mohamed Ben Abdellah University, Fes, Morocco

autor

Abourriche A.

• Laboratory Biomolecules and Organic Synthesis, Hassan 2 University, Casablanca, Morocco

autor

Bennamara A.

• Laboratory Biomolecules and Organic Synthesis, Hassan 2 University, Casablanca, Morocco

autor

Saffaj T.

• Laboratory of Applied Organic Chemistry, Sidi Mohamed Ben Abdellah University, Fes, Morocco

autor

Ihssane Bouchaib

• Laboratory of Applied Organic Chemistry, Sidi Mohamed Ben Abdellah University, Fes, Morocco

Bibliografia

• 1. McTaggart, F.; Jones, P. Cardiovasc. Drugs Ther. 2008, 22(4), 321–38.
• 2. Farnier, M. Presse Med. 1999, 28(36), 2002–10.
• 3. Bozhanov, S.; Maslarska, V. Pharmacia 2016, 63(2).
• 4. Sanjay, K.M.; Shruti, C.; Farhan, J.A., Roop, K.K. J. Saudi Chem. Soc. 2007, 250–6.
• 5. Sivakumar, T.; Manavalan, M.; Muralidharan, C.; Valliappan, K. J. Pharm. Biomed. Anal. 2007, 43, 1842–8.
• 6. Vamsi, K.M.; Rajendra, N.D.; Jalachandra, R.; Venugopal, P.; Sandeep, P.; Madhavi, G. J. Saudi. Chem. Soc. 2013. http://dx.doi.org/10.1016/j.jscs.2012. 12.001.
• 7. Molnár; Rieger, H.J.; Monks, K.E. J. Chromatogra. A 2010, 1217, 3193–3200.
• 8. Ebrahimzadeh, H.; Asgharinezhad, A.A.; Abedi, H.; Kamarei, F. Talanta 2011, 85, 1043–9.
• 9. Ebrahimzadeh, H.; Shekari, N.; Saharkhiz, Z.; Asgharinezhad, A.A. Talanta 2012, 94, 77–83.
• 10. ICH Q8 (R2). Pharmaceutical development 2009. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH.
• 11. Choi, G.; Le, T.-H.; Shin, S. Total. Qual. Manag. Bus. Excell. 2016, 804–17.
• 12. Morgan, E. J. Wiley, Chichester J. Chemometr. 1995. ISBN 0-471-95832-8, p. 275, £19.99.
• 13. Montgomery, D.C. Design and analysis of experiments, 5 ed.; Wiley: NewYork, 2001.
• 14. Elazazy, M.S.; Ganesh, K.; Sivakumar, V.; Huessein, Y.H.A. RSC Adv 2016, 6, 64967–76.
• 15. Elazazy, M.S. RSC Adv 2015, 5, 48474–83.
• 16. Abdel-Aziz, O.; Ayad, M.F., Tadros, M.M. Spectrochim. Acta A 2015, 140, 229–40.
• 17. Korany, M.; Ragab, M.; Youssef, R.; Afify, M. RSC Adv 2015, 5, 6385–94.
• 18. Ibrahim, F.A.; El-Yazbi, A.F., Wagih, M.M., Barary, M.A. Spectrochim. Acta A 2017, 184, 47–60.
• 19. Omar, M.A.; Ahmed, H.M.; Hammad, M.A.; Derayea, S.M. Spectrochim. Acta A 2015, 135, 472–8.
• 20. Leardi, R. Anal. Chim. Acta 2009, 652, 161–72.
• 21. Plackett, R.L.; Burman, J.P. Biometrika 1946, 33, 305–25.
• 22. Marcos, A.B.; Ricardo, E.S.; Eliane, P.O.; Leonardo, S.V.; Luciane, A.E. Talanta 2008, 76, 965–77.
• 23. Box, G.E.P.; Wilson, K.B. J. Roy. Stat. Soc., B 1951, 13, 1.
• 24. Goupy, J.L. Revue de statistique appliquée, Tome 1990, 38(4), 22.
• 25. Nuno, R.C.; Jo~ao, L.; Zulema, L.P. Chemom. Intell. Lab. Syst. 2011, 107, 234–44.
• 26. Ihssane, B.; Charrouf, M.; Abourriche, A.; Abboud, Y.; Bouabidi, A.; Bennamara, A.; Saffaj, T. Acta Chromatogr 2011, 23(1), 41–57.