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A simple HPLC method containing greener modifier and slighter temperature elevated for simultaneous determination of three statin drugs in tablets

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Statins drugs are thought to be among the most prescribed drugs worldwide for the treatment of hypercholesterolaemia. A simple and reliable RP-HPLC method has been successfully employed for simultaneously separating and qualifying three statin drugs including atorvastatin, rosuvastatin and simvastatin in pharmaceutical tablets. The optimal conditions were mobile phase 50:50 (v/v) (formic acid pH 2.50: ETOH), column temperature 40.00 °C, detection wavelength 238.00 nm, and flow rate 1.00 mL/min. The proposed method has been validated based on the ICH guidelines in terms of linearity, precision, accuracy, and limit of detection and limit of quantification. The linear range investigated 2.0–80.0, 4.0–100.00, and 12.00–120.00 µg/mL for rosuvastatin, atorvastatin and simvastatin respectively with coefficients of determination (R2) within the range of 0.9993–0.9995. The LOD and LOQ for rosuvastatin, atorvastatin and simvastatin were (1.57, 4.76 µg/mL), (1.87, 5.66 µg/mL), (3.46, 10.49 µg/mL) respectively. In addition, in order to evaluate the feasibility of the method developed, it was employed towards the quantification of the pharmaceutical tablets for the analytes investigated and excellent recovery was obtained.
Słowa kluczowe
Rocznik
Strony
210--215
Opis fizyczny
Bibliogr. 18 poz., rys., tab.
Twórcy
  • Department of Chemistry, College of Science, University of Jeddah, P.O. 80327, 21589, Jeddah, Saudi Arabia
  • Chemistry Department, Faculty of Science, King Abdulaziz University, 80203 Jeddah, Saudi Arabia
  • Jammom Pharmaceutical Company, P.O. 6267, 21442, Jeddah, Saudi Arabia
  • Department of Chemistry, College of Science, University of Jeddah, P.O. 80327, 21589, Jeddah, Saudi Arabia
  • Chemistry Department, Faculty of Science, King Abdulaziz University, 80203 Jeddah, Saudi Arabia
Bibliografia
  • 1. Calderon, R. M.; Cubeddu, L. X.; Goldberg, R. B.; Schiff, E. R. Statins in the treatment of dyslipidemia in the presence of elevated liver aminotransferase levels: A therapeutic dilemma. Mayo Clinic Proc. 2010, 85(4), 349–56.
  • 2. Liao, J. K.; Laufs, U. Pleiotropic effects of statins. Annu. Rev. Pharmacol. Toxicol. 2005, 45, 89–118.
  • 3. Schachter, M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam. Clin. Pharmacol. 2005, 19(1), 117–25.
  • 4. Patel, M.; Kothari, C. Critical review of statins: a bio-analytical perspective for therapeutic drug monitoring. TrAC Trends Anal. Chem. 2017, 86, 206–21.
  • 5. Abdallah, O. M. RP-HPLC determination of three anti-hyperlipidemic drugs in spiked human plasma and in dosage forms. EJournal Chem. 2011, 8(2), 753–61.
  • 6. Delhi Raj, N.; Kumaravel, S.; Murugan, R.; Sriman Narayanan, S.; Vijayalakshmi, R. Reverse phase HPLC method for the determination of Pravastatin in tablet dosage forms. Int. J. Res. Pharm. Sci. 2010, 1, 187–9.
  • 7. Płotka, J.; Tobiszewski, M.; Sulej, A. M.; Kupska, M.; Górecki, T.; Namieśnik, J. Green chromatography. J. Chromatogr. A 2013, 1307, 1–20.
  • 8. Yang, Y.; Strickland, Z.; Kapalavavi, B.; Marple, R.; Gamsky, C. Industrial application of green chromatography–I. Separation and analysis of niacinamide in skincare creams using pure water as the mobile phase. Talanta 2011, 84(1), 169–74.
  • 9. Fi, L.; Coutinho, M.; Nazario, C. E. D.; Monteiro, A. M.; Lanças, F. M. Novel devices for solvent delivery and temperature programming designed for capillary liquid chromatography. J. Sep. Sci. 2014, 37(15), 1903–10.
  • 10. Assassi, A. L.; Roy, C. -E.; Perovitch, P.; Auzerie, J.; Hamon, T.; Gaudin, K. Green analytical method development for statin analysis. J. Chromatogr. A. 2015, 1380, 104–11.
  • 11. Capello, C. F. U. Hungerbuhler, K What is a green solvent? A comprehensive framework environmental assessment solvents. Green. Chem. 2007, 9(9), 927–34.
  • 12. Studzińska, S.; Buszewski, B. Effect of mobile phase pH on the retention of nucleotides on different stationary phases for highperformance liquid chromatography. Anal. Bioanal. Chem. 2013, 405(5), 1663–72.
  • 13. Jiang, Z.; Smith, N. W.; Ferguson, P. D.; Taylor, M. R. Mixed-mode reversed-phase and ion-exchange monolithic columns for micro-HPLC. J. Sep. Sci. 2008, 31(15), 2774–83.
  • 14. Teutenberg, T.; Hollebekkers, K.; Wiese, S.; Boergers, A. Temperature and pH-stability of commercial stationary phases. J. Sep. Sci. 2009, 32(9), 1262–74.
  • 15. Knox, J. H.; Scott, H. P. B and C terms in the Van Deemter equation for liquid chromatography. J. Chromatogr. A 1983, 282, 297–313.
  • 16. Gajra, B.; Patel, M.; Patel, D. A. Validation of analytical procedures: methodology ICH-Q2B. Int. J. Pharm. Innovations-2249-1031 2011, 1, 45–50.
  • 17. Tuzimski, T.; Petruczynik, A. Review of chromatographic methods coupled with modern detection techniques applied in the therapeutic drugs monitoring (TDM). Molecules 2020, 25 (17), 4026.
  • 18. Alshitari, W.; Quigley, C. L.; Smith, N. Fabrication and evaluation of an organic monolithic column based upon the polymerisation of hexyl methacrylate with 1,6-hexanediol ethoxylate diacrylate for the separation of small molecules by capillary liquid chromatography.Talanta 2015, 141, 103–10.
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-a725a72a-ad08-46f1-8685-1a8194fa2851
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