The use of an RP-HPLC-UV method for the analysis of oxcarbazepine in the presence of its preservatives; stability studies and application to human plasma Samales

• Autorzy: Fouad Ali , Abdelkhalek Ahmed S. , Elrefay Hisham , Batakoushy Hany , Soltan Moustafa K.

Identyfikatory

DOI

10.1556/1326.2023.01157

• Języki publikacji: EN

Abstrakty

EN

A simple, sensitive, selective, accurate and precise method was developed and fully validated for determination of oxcarbazepine (OXC) in presence of their preservatives and determination of oxcarbazepine (OXC) in human plasma. A reversed phase liquid chromatography (RP-HPLC) with UV detection techniques were applied for separation and quantification of studied drug OXC. Successful separation of the drug from methyl paraben (M.P.), propyl paraben (P.P.) and potassium sorbate (P.ST.) was achieved on a Kromasil C18 column (5 μm particle size, pore size 300 Å, l3I.D. 25034.6 mm). The mobile phase that contain aqueous 0.05M potassium dihydrogen phosphate buffer (pH 7): acetonitrile, (50: 50, %v/v). The method was linear over concentration ranges 5.0–50 μg mL1 for OXC. Bioanalytical validation of the developed method was carried out according to US-FDA guidelines and revealed a good linear relations over a range of (5.0–50), (0.5–10), (0.05–0.15), and (1.0–10) μg mL1 for OXC, M.P, P.P, and P.ST, respectively, with a correlation coefficient (R2) of more than 0.999. Limit of detection (LOD) were 1.15, 0.03, 0.01 and 0.04 μg mL1 for OXC, M.P, P.P, and P.ST, respectively, Intra and inter-day precisions, calculated as percentage relative standard deviation (% RSD), were lower than 2.0%. The developed method can be applied for routine drug analysis, therapeutic drug monitoring and bioequivalence studies through the analysis of plasma samples taken from blood bank.

Słowa kluczowe

EN

bioanalytical validation; oxcarbazepine; preservatives; plasma and RP-HPLC

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2024
• Tom: Vol. 36, no. 3
• Strony: 247--255
• Opis fizyczny: Bibliogr. 33 poz., rys., wykr.

Twórcy

autor

Fouad Ali

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut, 71524, Egypt

autor

Abdelkhalek Ahmed S.

• Department of Medicinal Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt
• Department of Medicinal Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt

autor

Elrefay Hisham

• Simco Pharmaceutical Industries, 6th of October, Egypt

autor

Batakoushy Hany

• Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Menoufia University, Shebin Elkom, 32511, Egypt

autor

Soltan Moustafa K.

• Oman College of Health Sciences, Ministry of Health, Muscat, Sultanate of Oman

Bibliografia

• 1. USP, T.U.S.P., 39th ed., United States Pharmacopoeial, R. Convention, MD, USA, 2016, pp. 5687e5694. Monograph for, and O.O.S. Oxcarbazepine, and Oxcarbazepine Tablets.
• 2. Glauser, T. A. Oxcarbazepine in the treatment of epilepsy. Pharmacother. J. Hum. Pharmacol. Drug Ther. 2001, 21(8), 904–19.
• 3. Walsh, J.; Ranmal, S. R.; Ernest, T. B.; Liu, F. Patient acceptability, safety and access: a balancing act for selecting age-appropriate oral dosage forms for paediatric and geriatric populations. Int. J. Pharm. 2018, 536(2), 547–62.
• 4. Mirsonbol, S. Z.; Issazadeh, K.; Pahlaviani, M. R. M. K.; Momeni, N. Antimicrobial efficacy of the methylparaben and benzoate sodium against selected standard microorganisms, clinical and environment al isolates in vitro. Vitro. Indian J. Fundam. Appl. Life Sci. 2014, 4(S4), 363–7.
• 5. M Kashid, R.; Singh, S. G.; Singh, S. Simultaneous determination of preservatives (methyl paraben and propyl paraben) in sucralfate suspension using high performance liquid chromatography. E-Journal Chem. 2011, 8(1), 340–6.
• 6. Saad, B.; Bari, M. F.; Saleh, M. I.; Ahmad, K; Talib, M. K. M. Simultaneous determination of preservatives (benzoic acid, sorbic acid, methylparaben and propylparaben) in foodstuffs using high performance liquid chromatography. J. Chromatogr. A 2005, 1073(1–2), 393–7.
• 7. Pradhan, D. P.; Annapurna, M. M. Stability indicating HPLC-DAD method for the determination of Oxcarbazepine-An Anticonvulsant. Res. J. Pharm. Technol. 2019, 12(2), 723–8.
• 8. Qi, M.; Wang, P.; Wang, L. J.; Fu, R. N. LC method for the determination of oxcarbazepine in pharmaceutical preparations. J. Pharm. Biomed. Anal. 2003, 31(1), 57–62.
• 9. Franceschi, L.; Furlanut, M. A simple method to monitor plasma concentrations of oxcarbazepine, carbamazepine, their main metabolites and lamotrigine in epileptic patients. Pharmacol. Res. 2005, 51(4), 297–302.
• 10. Žirojevic, J.; Drljevic-Ðuric, K.; Ðurdevic, A. Determination of oxcarbazepine and its related substances using UHPLC method with UV detection. Arh Farm 2014, 64, 83–94.
• 11. Fortuna, A.; Sousa, J.; Alves, G.; Falcão, A.; Soares-da-Silva, P. Development and validation of an HPLC-UV method for the simultaneous quantification of carbamazepine, oxcarbazepine, eslicarbazepine acetate and their main metabolites in human plasma. Anal. Bioanal. Chem. 2010, 397(4), 1605–15.
• 12. Breton, H.; Cociglio, M.; Bressolle, F.; Peyriere, H.; Blayac, J. P.; Hillaire-Buys, D. Liquid chromatography–electrospray mass spektrometry determination of carbamazepine, oxcarbazepine and Wight of their metabolites in human plasma. J. Chromatogr. B 2005, 828(1–2), 80–90.
• 13. Menge, G.; Dubois, J. Determination of oxcarbazepine in human plasma by high-performance liquid chromatography. J. Chromatogr. B: Biomed. Sci. Appl. 1983, 275, 189–94.
• 14. Rouan, M. Automated microanalysis of oxcarbazepine and its monohydroxy and transdiol metabolites in plasma by liquid chromatography. J. Chromatogr. B: Biomed. Sci. Appl. 1994, 658(1), 167–72.
• 15. Levert, H.; Odou, P.; Robert, H. LC determination of oxcarbazepine and its active metabolite in human serum. J. Pharm. Biomed. Anal. 2002, 28(3-4), 517–25.
• 16. Mandrioli, R.; Ghedini, N.; Albani, F.; Kenndler, E.; Raggi, M. A. Liquid chromatographic determination of oxcarbazepine and its metabolites in plasma of epileptic patients after solid-phase extraction. J. Chromatogr. B 2003, 783(1), 253–63.
• 17. Liu, M.; Wang, Y.; Jiang, Y.; Liu, H.; Chen, J.; Liu, S. Quantitation of oxcarbazepine clinically in plasma using surfaced-enhanced Raman spectroscopy (SERS) coupled with chemometrics. Appl. Spectrosc. 2019, 73(7), 801–9.
• 18. Pylypiw, H. M., Jr; Grether, M. T. Rapid high-performance liquid chromatography method for the analysis of sodium benzoate and potassium sorbate in foods. J. Chromatogr. A 2000, 883(1-2), 299–304.
• 19. Gören, A. C.; Bilsel, G.; S¸ims¸ek, A.; Bilsel, M.; Akçadag, F.; Topal, K.; Ozgen, H. HPLC and LC–MS/MS methods for determination of sodium benzoate and potassium sorbate in food and beverages: performances of local accredited laboratories via proficiency tests In Turkey. Food Chem. 2015, 175, 273–9.
• 20. Kreuz, D. M.; Howard, A. L.; Ip, D. Determination of indinavir, potassium sorbate, methylparaben, and propylparaben in aqueous pediatric suspensions. J. Pharm. Biomed. Anal. 1999, 19(5), 725–35.
• 21. Can, N. O.; Arli, G.; Lafci, Y. A novel RP‐HPLC method for simultaneous determination of potassium sorbate and sodium benzoate in soft drinks using C18‐bonded monolithic silica column. J. Separat. Sci. 2011, 34(16–17), 2214–22.
• 22. Byrne, J.; Velasco-Torrijos, T.; Reinhardt, R. Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation. J. Pharm. Biomed. Anal. 2014, 96, 111–7.
• 23. Javed, M. F.; Zahra, M.; Javed, I.; Ahmad, S.; Jabeen, T.; Ahmad, M. Development and validation of RP HPLC method for the estimation of methyl paraben sodium and propyl paraben sodium in iron 254 Acta Chromatographica 36 (2024) 3, 247–255
• 24. Tartaglia, A.; Kabir, A.; Ulusoy, S.; Sperandio, E.; Piccolantonio, S.; Ulusoy, H. I.; Locatelli, M. FPSE-HPLC-PDA analysis of seven paraben residues in human whole blood, plasma, and urine. J. Chromatogr. B 2019, 1125, 121707.
• 25. Elrefay, H.; Ismaiel, O.; Hassan, W. S.; Shalaby, A.; Fouad, A. Simultaneous determination of levetiracetam and preservatives In oral solution formulation using HPLC-Uv method with a programble detection wavelength. Eurasian J. Anal. Chem. 2019, 14(4), 25–31.
• 26. Elrefay, H. A.; Ismaiel, O. S.; Hassan, W.; Shalaby, A.; Fouad, A. A validated rapid reversed-phase high performance liquid chromatographic method for determination of risperidone and benzoil acid. Eurasian J. Anal. Chem. 2020, 15(1).
• 27. El-Adl, S. M.; El-Shanawany, A. A.; Abdel-Aziz, L. M.; Hassan, A. F. HPLC determination of three cephalosporins (cefepime, cefotriaxone and cefotaxime) in their bulk and dosage forms. Asian J. Pharm. Anal. 2014, 4(3), 91–7.
• 28. Elrefay, H.; Ismaiel, O. A; Hassan, W. S.; Shalaby, A.; Fouad, A. RPHPLC stability-indicating method for simultaneous determination of sodium valproate, methylparaben and propylparaben in oral solution. Acta Chromatographica 2021, 34(2), 203–9.
• 29. Elrefay, H.; Ismaiel, O. A.; Hassan, W. S.; Shalaby, A.; Fouad, A.; Sebaiy, M. M. Mini-review on various analytical methods for determination of certain preservatives in different matrices. Int. J. Res. Stud. Sci. Eng. Technol.(IJRSSET) 2021, 8(2), 1–8.
• 30. El-Abasawy, N. M.; Sharaf El-din, M. M.; EL-Olemy, A.; Fouad, A. Determination of alogliptin benzoate and pioglitazone hydrochloride in their dosage forms, validation and stability-indicating studies using RP-HPLC method. Octahedron Drug Res. 2023, 2(1), 1–10.
• 31. Opuni, K. F.; Boadu, J. A.; Amponsah, S. K.; Okai, C. A. High performance liquid chromatography: a versatile tool for assaying antiepileptic drugs in biological matrices. J. Chromatogr. B 2021, 1179, 122750.
• 32. Guideline, I. Q2 (R1). Validation Anal. Procedures: Text Methodol. 2005, 541.
• 33. Zimmer, D. New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR. Bioanalysis 2014, 6(1), 13–9.