RP-HPLC stability-indicating method for simultaneous determination of sodium valproate, methylparaben and propylparaben in oral solution

• Autorzy: Elrefay Hisham , Ismaiel Omnia A. , Hassan Wafaa S. , Shalaby Abdalla , Fouad Ali

Identyfikatory

DOI

10.1556/1326.2021.00907

• Języki publikacji: EN

Abstrakty

EN

A new, sensitive, stability-indicating reversed-phase HPLC method was validated and applied for the simultaneous quantitation of sodium valproate and two paraben preservatives; methylparaben, and propylparaben in the liquid dosage form. Stability tests were carried out through exposure of the analyte's solution to stress conditions. Separation of the analytes was achieved on (waters) C18 Column (150 mm × 3.9 mm, 5 μm). A mixture of 0.05 M monobasic potassium phosphate pH 3.5 and acetonitrile (50:50; v/v) was applied at 1.5 ml/min flow rate and UV detection wavelength at 210 nm. The degradation products and the analytes were completely separated. The linearity was performed in the range of 50–150 % from a target concentration of 10 μg/ml propylparaben, 90 μg/ml methylparaben, and 2.88 mg/ml sodium valproate with a coefficient correlation (R2) 1.0 for methylparaben, propylparaben and sodium valproate. The validation results of the suggested method were in a good agreement with ICH guidelines. Application of the proposed method for analysis of liquid dosage forms was successfully carried out in the routine quality control process.

Słowa kluczowe

EN

methylparaben; propylparaben; sodium valproate; stability-indicating RP-HPLC; stress degradation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2022
• Tom: Vol. 34, no. 2
• Strony: 203--209
• Opis fizyczny: Bibliogr. 27 poz., rys., tab.

Twórcy

autor

Elrefay Hisham

• Simco Pharmaceutical Industries, 6th of October, Egypt

autor

Ismaiel Omnia A.

• Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Egypt

autor

Hassan Wafaa S.

• Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Egypt

autor

Shalaby Abdalla

• Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Egypt

autor

Fouad Ali

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

• https://orcid.org/0000-0003-4330-9932

Bibliografia

• 1. United States Pharmacopoeia NF. USP30; United States Pharmacopoeial Convention, Inc, 2007.
• 2. Andersen, F. A. Final amended report on the safety assessment of methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, isobutylparaben, and benzylparaben as used in cosmetic products. Int. J. Toxicol. 2008, 27, 1–82. https://doi.org/10.1177/109158180802704s01.
• 3. Kumar, S.; Mathkar, S.; Romero, C.; Rustum, A. M. Development and validation of a single RP-HPLC assay method for analysis of bulk raw material batches of four parabens that are widely used as preservatives in pharmaceutical and cosmetic products. J. Chromatogr. Sci. 2011, 49, 405–11.
• 4. Peng, X.; Adachi, K.; Chen, C.; Kasai, H.; Kanoh, K.; Shizuri, Y.; Misawa, N. Discovery of a marine bacterium producing 4- hydroxybenzoate and its alkyl esters, parabens. Appl. Environ. Microbiol. 2006, 72, 5556–61.
• 5. Gopalakrishnan, S.; Chitra, T. A.; Aruna, A.; Chenthilnathan, A. Development of RP-HPLC method for the simultaneous estimation of ambroxol hydrochloride, cetirizine hydrochloride and antimicrobial preservatives in combined dosage form. Der Pharma Chem. 2012, 4, 1003–15.
• 6. The British Pharmacopoeia; Her Majesty’s Stationary Office: London, 2009.
• 7. Shabir, G. A. A new validated HPLC method for the simultaneous determination of 2-phenoxyethanol, methylparaben, ethylparaben and propylparaben in a pharmaceutical gel. Indian J. Pharm. Sci. 2010, 72, 421–5.
• 8. Kumar, N.; Vaghela, B.; Reddy, P. S.; Sangeetha, D. Development and validation of a novel stability indicating RP-UPLC method for simultaneous determination of nizatidine, methylparaben and propylparaben in oral liquid pharmaceutical formulation. Quim Nova 2012, 35, 827–31.
• 9. Baranowska, I.; Wojciechowska, I; Solarz, N.; Krutysza, E. Determination of preservatives in cosmetics, cleaning agents and pharmaceuticals using fast liquid chromatography. J. Chromatogr. Sci. 2013, 52, 88–94.
• 10. Kwan, P.; Sills, G. J.; Brodie, M. J. The mechanisms of action of commonly used antiepileptic drugs. Pharmacol. Ther. 2001, 90, 21–34.
• 11. Willmore, L. J. Divalproex and epilepsy. Psychopharmacol. Bull. 2003, 37, 43–53.
• 12. Chen, Z.; Wang, X.; Wang, H.; Shu-Da, C.; Lie-Min, Z.; Jia-Li, L.; Wen-Ying, S.; Jue-Qian, Z.; Zi-Yan, F.; Yu, Z.; Min, H. Simultaneous determination of valproic acid and 2-propyl-4-pentenoic acid for the prediction of clinical adverse effects in Chinese patients with epilepsy. Seizure 2012, 21, 110–7.
• 13. Dai, B.; Zhang, H.; Song, Q.; Xu, F. Determination the concentrations of phenobarbital, sodium valproate, phenytoin sodium and carbamazepine in human plasma for simultaneous quatification by HPLC-MS. Chinese J Clin Pharmacol. 2011, 3, 14.
• 14. Mohammadi, B.; Majnooni, M. B.; Khatabi, P. M.; Jalili, R.; Bahrami, G. 9-Fluorenylmethyl chloroformate as a fluorescence-labeling reagent for derivatization of carboxylic acid moiety of sodium valproate using liquid chromatography/tandem mass spectrometry for binding characterization: a human pharmacokinetic study. J. Chromatogr. B 2012, 880, 12–8.
• 15. Belal, T. S.; El-Kafrawy, D. S.; Mahrous, M. S.; Muthuraja, S.; Roopan, S. M. Validated spectrophotometric methods for determination of sodium valproate based on charge transfer complexation reactions. Spectrochim Acta Part A. Mol. Biomol. Spectrosc. 2016, 155, 47–53. https://doi.org/10.1016/j.saa.2015.11.008.
• 16. Sorouraddin, M. H.; Imani-Nabiyyi, A.; Najibi-Gehraz, S. A.; Rashidi, M. R. A new fluorimetric method for determination of valproic acid using TGA-capped CdTe quantum dots as proton sensor. J. Lumin. 2014, 145, 253–8. https://doi.org/10.1016/j.jlumin.2013.07.025.
• 17. Amini-Shirazi, N.; Ahmadkhamha, R.; Shadma, S.; Ghahremani, M. H.; Abdollahi, M.; Dadgar, A.; Kebriaeezadeh, A. Determination of VPA and its two important metabolites in Iranian overdosed patients. Int. J. Pharmacol. 2010, 6, 854–62.
• 18. Sobhi, H. R.; Kashtiaray, A.; Farahani, H.; Abrahimpour, F.; Esrafili, A. Quantitation of valproic acid in pharmaceutical preparations using dispersive liquid liquid microextraction followed by gas chromatography flame ionization detection without prior derivatization. Drug Test Anal. 2010, 2, 362–6.
• 19. European Medicines Agency (EMA) Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product. London, 2007.
• 20. ICH Harmonized Tripartite Guideline Validation of Analytical Procedures: Text and Methodology, Q2 (R1). Geneva, 2005.
• 21. Fouad, A.; Shaykoon, M. S. A.; Ibrahim, S. M.; El-Adl, S. M.; Ghanem, A. Colistin sulfate chiral stationary phase for the enantioselective separation of pharmaceuticals using organic polymer monolithic capillary chromatography. Molecules 2019, 24(5), 833.
• 22. Fouad, A.; Marzouk, A. A.; Ibrahim, S. M.; Sobhy, M.; Ghanem, A. Functionalized polymer monoliths with carbamylated amylose for the enantioselective reversed phase nano-liquid chromatographic separation of a set of racemic pharmaceuticals. J. Chromatogr. A2017, 1515, 91–9.
• 23. Fouad, A.; Ibrahim, D.; Adly, F. G.; Ghanem, A. An insight into chiral monolithic stationary phases for enantioselective high-performance liquid chromatography applications. J. Separat. Sci 2019, 42(14), 2303–40.
• 24. 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.
• 25 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 benzoic acid. Eurasian J. Anal. Chem. 2020, 15(1), emEJAC-00393.
• 26. 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.
• 27. Reddy, S. R.; Reddy, K. H.; Reddy, P. M.; Reddy, G. A.; Kumar, M. N.; Sharma, H. K. Reliable GC method for related substances in divalproex sodium drug. J. Chromatogr. Sci. 2017, 55(9), 891–8.

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).