Development and validation of an isocratic HPLC method for simultaneous determination of quaternary mixtures of antihypertensive drugs in pharmaceutical formulations

• Autorzy: Anderson J. F. F. , Gerlin M. C. G. , Sversut R. A. , Oliveira L. C. S. , Singh A. K. , Amaral M. S. , Kassab N. M.

Identyfikatory

DOI

10.1556/1326.2017.29.1.9

• Języki publikacji: EN

Abstrakty

EN

The objective of this study was to develop and validate an assay method for simultaneous determination of atenolol, furosemide, losartan, and spironolactone in pharmaceutical formulations. A reverse-phase high-performance liquid chromatography procedure was developed, using a Kinetex® C-18 column (100 mm × 4.6 mm, 2.6 μm). The mobile phase was composed of metanol-water (75:25 v/v, pH 3.0, adjusted with phosphoric acid), with a flow rate of 0.4 mL min^-1. All drugs were separated in less than 5 min. The method was validated according to International Conference on Harmonization (ICH) and Association of Official Analytical Chemists (AOAC) guidelines. The method showed linearity in a concentration range of 0.75–12.0 μg Ml^-1 for atenolol (r = 0.9995), 0.30–12.00 μg Ml^-1 for furosemide (r = 0.9997), 0.45–12.00 μg Ml^-1 for losartan (r = 0.9995), and 0.45–12.0 μg Ml^-1 for spironolactone (r = 0.9999). The method also showed repeatability and precision. The three-day average intra-day precisions were 101.35 ± 0.74% for atenolol, 95.84 ± 1.44% for furosemide, 98.90 ± 1.16% for losartan, and 97.19 ± 0.18% for spironolactone. Similarly, the inter-day precisions were 101.34 ± 0.72% for atenolol, 95.84 ± 0.1.50% for furosemide, 98.90 ± 1.17% for losartan, and 97.19 ± 0.83% for spironolactone. The method accuracy was also tested and validated - in this case, the average recovery values were 100.18 ± 1.20% for atenolol, 99.83 ± 1.54% for furosemide, 100.07 ± 0.95% for losartan, and 99.94 ± 0.93% for spironolactone. Finally, the method was successfully applied in the simultaneous determination of atenolol, furosemide, losartan, and spironolactone in magisterial formulas, as well as in commercial pharmaceutical formulations.

Słowa kluczowe

EN

HPLC-DAD; antihypertensive; quality control; simultaneous determination; quantitative

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2017
• Tom: Vol. 29, no. 1
• Strony: 95--110
• Opis fizyczny: Bibliogr. 33 poz., rys., tab.

Twórcy

autor

Anderson J. F. F.

• Programa de Pós-Graduação em Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Mato Grosso do Sul, Brazil

autor

Gerlin M. C. G.

• Programa de Pós-Graduação em Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Mato Grosso do Sul, Brazil

autor

Sversut R. A.

• Programa de Pós-Graduação em Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Mato Grosso do Sul, Brazil

autor

Oliveira L. C. S.

• Instituto de Química, Universidade Federal de Mato Grosso do Sul, Brazil

autor

Singh A. K.

• Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, 05508-900, São Paulo, SP, Brazil

autor

Amaral M. S.

• Programa de Pós-Graduação em Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Mato Grosso do Sul, Brazil
• Instituto de Física, Universidade Federal de Mato Grosso do Sul, Brazil

autor

Kassab N. M.

• Programa de Pós-Graduação em Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Federal de Mato Grosso do Sul, Brazil

Bibliografia

• [1] ANVISA — Agência Nacional de Vigilância Sanitária (Brasil). Guia para Registro de Associações em Dose Fixa para o Tratamento da Hipertensão Arterial Brasil/ Agência Nacional de Vigilância Sanitária. ANVISA, Brasília, 2010
• [2] Goodman & Gilman. As Bases Farmacológicas da Terapêutica, 10th edn., McGraw- Hill, Rio de Janeiro, 2003
• [3] H.P. Rang, M.M. Dale, J.M. Ritter, and R.J. Flower, Rang & Dale Farmacologia, 6th edn., Elsevier, Rio de Janeiro, 2007
• [4] M. van der Heijden, S.H. Donders, T.J. Cleophas, M.G. Niemeyer, J. van der Meulen, P. J. Bernick, B.A. de Planque, and E.E. van der Wall for the BUFUL Study Group, J. Clin. Pharmacol., 38, 630–635 (1998)
• [5] B. Pitt, F. Zannad, W.J. Remme, R. Cody, A. Castaige, A. Perez, J. Palensky, and J. Wittes for the Randomized Aldactone Evaluation Study Investigators, N. Engl. J. Med., 276, 359–366 (1999)
• [6] L.A. Bortolotto, Revista Brasileira de Hipertensão, 10, 260–264 (2003)
• [7] R.C.P. Azevedo, G.P. Ribeiro, and M.B. Araújo, Rev. Bras. Cienc. Farm., 44 (2), (2008)
• [8] V Diretrizes Brasileiras de Hipertensão Arterial, São Paulo, 2006.
• [9] VI Diretrizes Brasileiras de Hipertensão, Rev. Bras. Hipertens., 17, 31–43 (2010)
• [10] N.M. Bhatia, S.B. Gurav, S.D. Jadhav, and M.S. Bhatia, J. Liq. Chromatogr. Rel. Technol., 35, 428–443 (2012)
• [11] M. Delamoye, C. Duverneuil, P. François, P. Mazancourt, and J. Alvarez, Forensic Sci. Int., 141, 23–31 (2004)
• [12] P.B. Deshpande, S.V.V. Gandhi, N.V. Gaikwad, and K.S. Khandagle, Acta Chromatogr., 24, 15–22, (2012)
• [13] W.M. Ebeid, E.F. Elkady, A.A. El-Zaher, and E.I. El-Bagary, J. Sep. Sci., 37, 748–757 (2014)
• [14] S. Soltani, A.M. Ramezani, N. Soltani, and A. Jouyban, Bioanalysis, 4, 2805–2821 (2012)
• [15] M. Smajic, Z. Vujic, N. Mulavdic, and J. Brboric, Chromatographia, 76, 419–425 (2013)
• [16] C. Vishnuvardhan, P. Radhakrishnanand, S.G. Navalgund, K.R. Atcha, and N. Satheeshkumar, Chromatographia, 77, 265–275 (2014)
• [17] M.I. Walash, N. El-Enany, M.I. Eid, and M.E. Fathy, Anal. Methods, 5, 5644–5656 (2013)
• [18] A. Maslanka, J. Krzek, and M. Stolarczyk, J. Planar Chromatogr.–Mod. TLC, 22, 405–410 (2009)
• [19] K.M. Al Azzam, B. Saad, and H.Y. Aboul-Enein, Biomed. Chromatogr., 24, 948–953 (2010)
• [20] M.A. Obando, J.M. Estela, and V. Cerda, Anal. Bioanal. Chem., 391, 2349–2356 (2008)
• [21] S.A. Hussein, H.M. Abd El-Wadood, M.A.A. Abdallah, and A.A. Khorshed, J. Planar Chromatogr.–Mod. TLC, 27, 192–198 (2014)
• [22] K.S. Lakshmi and S. Lakshmi, J. Anal. Methods Chem., 2012, 5 (2012)
• [23] H.J. Panchal and B.N. Suhagia, Acta Chromatogr., 22, 173–187 (2010)
• [24] M.S. Arayne, N. Sultana, F. Qureshi, F.A. Siddiqui, A.Z. Mirza, S.S. Bahadur, and M.H. Zuberi, Chromatographia, 70, 789–795 (2009)
• [25] O. Gonzalez, G. Iriarte, E. Rico, N. Ferreiros, M.I. Maguregui, R.M. Alonso, and R.M. Jimenez, J. Chromatogr. B, 878, 2685–2692 (2010)
• [26] R.R. Kallem, J.K. Inamadugu, M. Ramesh, and J. V.L.N. Seshagirirao, Biomed. Chromatogr., 27, 349–355 (2013)
• [27] J.M. Beale and J.H. Block, Textbook of Organic Medicinal and Pharmaceutical Chemistry, 12th edn., Lippincott Williams & Wilkins, Philadelphia, 2011
• [28] E.M. Borges, K.E. Goraieb, and C.H. Collins, Quím. Nova, 35, 993–1003 (2012)
• [29] CDER Center for Drug Evaluation and Research, Reviewer Guidance Validation of Chromatographic Methods, 1994
• [30] ANVISA — Agência Nacional de Vigilância Sanitária. Resolução RDC nº 899 de 29 de maio de 2003. Aprova o guia para validação de métodos analíticos e bioanalíticos. Diário Oficialda União. Brasília, 02 de junho de 2003, seção 1, 2003a
• [31] ICH Harmonised Tripartite Guideline. Validation of Analytical Methods: Definitions and Terminology. ICH Topic Q2A. London, 1994, p. 6
• [32] ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Methodology, ICH Topic Q2B. London, 1996, p. 10
• [33] AOAC — International Conference on Harmonization. Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Genova, 2006

Uwagi

PL

Opracowanie ze środków MNiSW w ramach umowy 812/P-DUN/2016 na działalność upowszechniającą naukę (zadania 2017).