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  • 1 Universidade Federal de Mato Grosso do Sul, Brazil
  • | 2 Universidade Federal de Mato Grosso do Sul, Brazil
  • | 3 Universidade de São Paulo, 05508-900, São Paulo, SP, Brazil
  • | 4 Universidade Federal de Mato Grosso do Sul, Brazil
Open access

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 methanol—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.

  • [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

    • Search Google Scholar
    • Export Citation
  • [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, 630635 (1998)

    • Search Google Scholar
    • Export Citation
  • [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, 359366 (1999)

    • Search Google Scholar
    • Export Citation
  • [6]

    L.A. Bortolotto, Revista Brasileira de Hipertensão, 10, 260264 (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, 3143 (2010)

  • [10]

    N.M. Bhatia, S.B. Gurav, S.D. Jadhav, and M.S. Bhatia, J. Liq. Chromatogr. Rel. Technol., 35, 428443 (2012)

  • [11]

    M. Delamoye, C. Duverneuil, P. François, P. Mazancourt, and J. Alvarez, Forensic Sci. Int., 141, 2331 (2004)

  • [12]

    P.B. Deshpande, S.V.V. Gandhi, N.V. Gaikwad, and K.S. Khandagle, Acta Chromatogr., 24, 1522, (2012)

  • [13]

    W.M. Ebeid, E.F. Elkady, A.A. El-Zaher, and E.I. El-Bagary, J. Sep. Sci., 37, 748757 (2014)

  • [14]

    S. Soltani, A.M. Ramezani, N. Soltani, and A. Jouyban, Bioanalysis, 4, 28052821 (2012)

  • [15]

    M. Smajic, Z. Vujic, N. Mulavdic, and J. Brboric, Chromatographia, 76, 419425 (2013)

  • [16]

    C. Vishnuvardhan, P. Radhakrishnanand, S.G. Navalgund, K.R. Atcha, and N. Satheeshkumar, Chromatographia, 77, 265275 (2014)

  • [17]

    M.I. Walash, N. El-Enany, M.I. Eid, and M.E. Fathy, Anal. Methods, 5, 56445656 (2013)

  • [18]

    A. Maslanka , J. Krzek, and M. Stolarczyk, J. Planar Chromatogr.–Mod. TLC, 22, 405410 (2009)

  • [19]

    K.M. Al Azzam , B. Saad, and H.Y. Aboul-Enein, Biomed. Chromatogr., 24, 948953 (2010)

  • [20]

    M.A. Obando, J.M. Estela, and V. Cerda, Anal. Bioanal. Chem., 391, 23492356 (2008)

  • [21]

    S.A. Hussein , H.M. Abd El-Wadood, M.A.A. Abdallah, and A.A. Khorshed, J. Planar Chromatogr.–Mod. TLC, 27, 192198 (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, 173187 (2010)

  • [24]

    M.S. Arayne, N. Sultana, F. Qureshi, F.A. Siddiqui, A.Z. Mirza, S.S. Bahadur, and M.H. Zuberi, Chromatographia, 70, 789795 (2009)

  • [25]

    O. Gonzalez, G. Iriarte, E. Rico, N. Ferreiros, M.I. Maguregui, R.M. Alonso, and R.M. Jimenez, J. Chromatogr. B, 878, 26852692 (2010)

    • Search Google Scholar
    • Export Citation
  • [26]

    R.R. Kallem, J.K. Inamadugu, M. Ramesh, and J. V.L.N. Seshagirirao, Biomed. Chromatogr., 27, 349355 (2013)

  • [27]

    J.M. Beale and J.H. Block, Textbook of Organic Medicinal and Pharmaceutical Chemistry, 12th edn., Lippincott Williams & Wilkins, Philadelphia, 2011

    • Search Google Scholar
    • Export Citation
  • [28]

    E.M. Borges, K.E. Goraieb, and C.H. Collins, Quím. Nova, 35, 9931003 (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

    • Search Google Scholar
    • Export Citation
  • [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

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Senior editors

Editor(s)-in-Chief: Kowalska, Teresa

Editor(s)-in-Chief: Sajewicz, Mieczyslaw

Editors(s) Danica Agbaba (University of Belgrade, Belgrade, Serbia);
Ivana Stanimirova-Daszykowska (University of Silesia, Katowice, Poland),
Monika Waksmundzka-Hajnos (Medical University of Lublin, Lublin, Poland)

Editorial Board

R. Bhushan (The Indian Institute of Technology, Roorkee, India)
J. Bojarski (Jagiellonian University, Kraków, Poland)
B. Chankvetadze (State University of Tbilisi, Tbilisi, Georgia)
M. Daszykowski (University of Silesia, Katowice, Poland)
T.H. Dzido (Medical University of Lublin, Lublin, Poland)
A. Felinger (University of Pécs, Pécs, Hungary)
K. Glowniak (Medical University of Lublin, Lublin, Poland)
B. Glód (Siedlce University of Natural Sciences and Humanities, Siedlce, Poland)
K. Kaczmarski (Rzeszow University of Technology, Rzeszów, Poland)
H. Kalász (Semmelweis University, Budapest, Hungary)
I. Klebovich (Semmelweis University, Budapest, Hungary)
A. Koch (Private Pharmacy, Hamburg, Germany)
Ł. Komsta (Medical University of Lublin, Lublin, Poland)
P. Kus (Univerity of Silesia, Katowice, Poland)
D. Mangelings (Free University of Brussels, Brussels, Belgium)
E. Mincsovics (Corvinus University of Budapest, Budapest, Hungary)
G. Morlock (Giessen University, Giessen, Germany)
J. Sherma (Lafayette College, Easton, PA, USA)
R. Skibiński (Medical University of Lublin, Lublin, Poland)
B. Spangenberg (Offenburg University of Applied Sciences, Germany)
T. Tuzimski (Medical University of Lublin, Lublin, Poland)
Y. Vander Heyden (Free University of Brussels, Brussels, Belgium)
A. Voelkel (Poznań University of Technology, Poznań, Poland)
B. Walczak (University of Silesia, Katowice, Poland)
W. Wasiak (Adam Mickiewicz University, Poznań, Poland)

KOWALSKA, TERESA
E-mail: kowalska@us.edu.pl

SAJEWICZ, MIECZYSLAW
E-mail:msajewic@us.edu.pl

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2020
 
Total Cites
650
WoS
Journal
Impact Factor
1,639
Rank by
Chemistry, Analytical 71/83 (Q4)
Impact Factor
 
Impact Factor
1,412
without
Journal Self Cites
5 Year
1,301
Impact Factor
Journal
0,34
Citation Indicator
 
Rank by Journal
Chemistry, Analytical 75/93 (Q4)
Citation Indicator
 
Citable
45
Items
Total
43
Articles
Total
2
Reviews
Scimago
28
H-index
Scimago
0,316
Journal Rank
Scimago
Chemistry (miscellaneous) Q3
Quartile Score
 
Scopus
393/181=2,2
Scite Score
 
Scopus
General Chemistry 215/398 (Q3)
Scite Score Rank
 
Scopus
0,560
SNIP
 
Days from
58
sumbission
 
to acceptance
 
Days from
68
acceptance
 
to publication
 
Acceptance
51%
Rate

2019  
Total Cites
WoS
495
Impact Factor 1,418
Impact Factor
without
Journal Self Cites
1,374
5 Year
Impact Factor
0,936
Immediacy
Index
0,460
Citable
Items
50
Total
Articles
50
Total
Reviews
0
Cited
Half-Life
6,2
Citing
Half-Life
8,3
Eigenfactor
Score
0,00048
Article Influence
Score
0,164
% Articles
in
Citable Items
100,00
Normalized
Eigenfactor
0,05895
Average
IF
Percentile
20,349
Scimago
H-index
26
Scimago
Journal Rank
0,255
Scopus
Scite Score
226/167=1,4
Scopus
Scite Score Rank
Chemistry (miscellaneous) 240/398 (Q3)
Scopus
SNIP
0,494
Acceptance
Rate
41%

 

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Acta Chromatographica
Language English
Size A4
Year of
Foundation
1992
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2021 Volume 33
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Founder Institute of Chemistry, University of Silesia
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ISSN 0236-6290 (Print)
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