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Implementation of different separation techniques for resolving ternary mixture of Paracetamol, Pseudoephedrine Hydrochloride and Chlorpheniramine maleate with further quantification

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Due to the wide applicability of separation techniques that rely on the property of differential migration in pharmaceutical formulations analysis, different analytical strategies have been proposed to resolve mixtures of multi-components pharmaceuticals. Three separation methods were developed and validated for the simultaneous determination of Paracetamol (PAR), Pseudoephedrine HCl (PSE) and Chlorpheniramine maleate (CHP). The first method is a thin-layer chromatographic (TLC) separation, followed by densitometric measurement. The separation was carried out on aluminium sheet of silica gel 60 F254 using ethanol:chloroform:ammonia (1:7:0.4, by volume) as the mobile phase. Determination of PAR, PSE and CHP was successfully applied over the concentration ranges of 3–25 µg/band, 0.5–10 µg/band and 0.1–6 µg/band, respectively. The second method is HPLC separation that was achieved on C18 column using the mobile phase acetonitrile:phosphate buffer pH 5 (10:90, v/v) at a flow rate 1 mL min⁻¹. PAR, PSE and CHP were determined by HPLC in concentration ranges of 5–400 μg mL⁻¹, 2–40 μg mL⁻¹ and 0.5–16 μg mL⁻¹, respectively. The third method is a capillary electrophoresis (CE) separation. The electrophoretic separation was achieved using 20 mM phosphate buffer (pH 6.5) at 20 kV. The linearity was reached over concentration ranges of 30–250 μg mL⁻¹, 5–50 μg mL⁻¹ and 0.8–20 μg mL⁻¹ for PAR, PSE and CHP, respectively. The developed methods were validated with respect to linearity, precision, accuracy and system suitability. The proposed methods were successfully applied for bulk powder and dosage form analysis with RSD of precision <2%. Moreover, statistical comparison with the official methods confirms the methods' validity.
Rocznik
Strony
351--360
Opis fizyczny
Bibliogr. 13 poz., rys., tab., wykr.
Twórcy
  • Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El-Aini, 11562, Cairo, Egypt
  • Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El-Aini, 11562, Cairo, Egypt
  • Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El-Aini, 11562, Cairo, Egypt
  • Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El-Aini, 11562, Cairo, Egypt
Bibliografia
  • 1. Simasek, M.; Blandino, D. Treatment of the common cold. Am. Fam. Phys. 2007, 75, 515–20.
  • 2. Picon, P. D.; Costa, M. B.; da Veiga Picon, R.; Fendt, L. C. C.; Suksteris, M. L.; Saccilotto, I. C.; Dornelles, A. D.; Schmidt, L. F. C. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect. Dis. 2013, 13, 1–8.
  • 3. British Pharmacopoeia. In British Pharmacopoeia, 5th ed.; Stationary Office, Appendix 1D: Buckingham Palace Road, London, UK, 2016.
  • 4. The United States of Pharmacopoeia-39/National Formulary-34. United States Pharmacopoeial Convention, Inc.: Rockville, Maryland, USA, 2016.
  • 5. Biemer, T. A. Simultaneous analysis of acetaminophen, pseudoephedrine hydrochloride and chlorpheniramine maleate in a cold tablet using an isocratic, mixed micellar high-performance liquid chromatographic mobile phase. J. Chromatogr. A 1987, 410, 206–10.
  • 6. Liao, Q.; Xie, Z.; Pan, B.; Zhu, C.; Yao, M.; Xu, X.; Wan, J. Lc–Ms–Ms simultaneous determination of paracetamol, pseudoephedrine and chlorpheniramine in human plasma: application to a pharmacokinetic study. Chromatographia 2008, 67, 687–94.
  • 7. Zou, H.; Gao, S.; Chen, W.; Zhong, Y.; Jiang, X.; Pei, Y. Simultaneous quantitation of paracetamol, pseudoephedrine and chlorpheniramine in dog plasma by Lc-Ms-Ms. Chromatographia 2008, 68, 251–7.
  • 8. Kalogria, E.; Koupparis, M.; Panderi, I. A porous graphitized carbon column Hplc method for the quantification of paracetamol, pseudoephedrine, and chlorpheniramine in a pharmaceutical formulation. J. AOAC Int. 2010, 93, 1093–101.
  • 9. Rajurkar, S. Simultaneous determination of chlorpheniramine maleate, paracetamol and pseudoephedrine hydrochloride in pharmaceutical preparations by Hplc. Int. J. Life Sci. Pharma Res. 2011, 1, 94–100.
  • 10. Dong, Y.-M.; Li, N.; An, Q.; Lu, N.-W. A novel nonionic micellar liquid chromatographic method for simultaneous determination of pseudoephedrine, paracetamol, and chlorpheniramine in cold compound preparations. J. Liquid Chromatogr. Relat. Tech. 2015, 38, 251–8.
  • 11. Weston, A.; Brown, P. R. High Performance Liquid Chromatography & Capillary Electrophoresis: Principles and Practices. Elsevier: San Diego, California, USA, 1997; p. 7–15.
  • 12. Variyar, P. S.; Chatterjee, S.; Sharma, A. Fundamentals and theory of Hptlc-based separation. In High-Performance Thin-Layer Chromatography (Hptlc), Springer: 2011; pp. 27–39.
  • 13. Adamovics, J. A. Chromatographic Analysis of Pharmaceuticals, 2nd ed.; Routledge: Madison Avenue, New York, USA, 2017, 74, 11-7.
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-bd4f8df3-7514-477b-a9e4-9434b546c04d
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