Two green and sensitive spectrofluorimetric approaches for determination of Ambroxol and guaifenesin in their single and combined pharmaceutical formulations.

cough preparations erythrosine B green chemistry native fluorescence spectrofluorimetry

Journal

Luminescence : the journal of biological and chemical luminescence
ISSN: 1522-7243
Titre abrégé: Luminescence
Pays: England
ID NLM: 100889025

Informations de publication

Date de publication:
Mar 2024
Historique:
revised: 09 01 2024
received: 27 10 2023
accepted: 16 02 2024
medline: 19 3 2024
pubmed: 19 3 2024
entrez: 19 3 2024
Statut: ppublish

Résumé

Ambroxol hydrochloride (AMX) and guaifenesin (GFN) are approved drugs utilized to treat coughs through their potent mucolytic and expectorant properties. Due to their massive, combined administration in many illnesses, there is a persistent need for their concurrent estimation in different pharmaceutical formulations. Two sensitive, environmentally friendly spectrofluorimetric methods were developed. AMX was determined using the first method (I) without interference from GFN. This method depends on the quenching of Erythrosine B (EB) native fluorescence at 552 nm after excitation at 527 nm due to the formation of a non-fluorescent AMX-EB ion-pair complex in Britton-Robinson buffer (BRB) solution pH (3.5). The concentration plot is linear over the 0.25-5.0 μg/mL range, with a mean percent found value of 99.74%. Method (II) depends on measuring the native fluorescence of aqueous GFN solution at two analytical wavelengths, either 300 or 600 nm, after excitation at 274 nm. Relative fluorescence intensity (RFI)-concentration plots are linear over the ranges of 0.02-0.5 and 0.1-2.0 μg/ml, with mean percent found at 99.96% and 99.91% at dual wavelengths, respectively. The proposed methods were successfully applied to assay both drugs in raw materials and different single and combined pharmaceutical formulations. These methods have been thoroughly validated following International Committee on Harmonisation (ICH) guidelines. National Environmental Methods Index, Analytical Eco-Scale, and Green Analytical Procedure Index were used to prove greenness, thereby enhancing their applicability. The proposed techniques provide straightforward, precise, and cost-effective solutions for routine formulation analysis in quality control laboratories.

Identifiants

pubmed: 38501299
doi: 10.1002/bio.4711
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e4711

Informations de copyright

© 2024 John Wiley & Sons Ltd.

Références

R. Buckingham, Martindale: The Complete Drug Reference, 40th ed., Pharmaceutical Press, London, UK 2020.
S. Md, S. T. Abdullah, N. A. Alhakamy, A. Bani-Jaber, A. K. Radhakrishnan, S. Karim, N. Shahzad, G. A. Gabr, A. J. Alamoudi, W. Y. Rizg, Gels 2021, 7(A549), 243.
X. Wang, L. Wang, H. Wang, H. Zhang, Biochem. Biophys. 2015, 73, 281.
BP, The British Pharmacopoeia, Her Majesty's Stationary Office, London, 2020.
European Pharmacopoeia Online version, Strasbourg, France, 2022, https://pheur.edqm.eu/home
V. Rele Rajan, J. Gurav Pankaj, Int. J. PharM. Tech. Res 2012, 4, 994.
A. El-Sayed, H. Elmansi, S. Shalan, M. Eid, Ann. Pharm. Fr. 2022, 687, 687.
S. Muralidharan, J. R. Kumar, S. A. Dhanara, J. Adv. Pharm. Tech& Res 2013, 4, 65.
P. Jain, J. Chromatogra. Sci. 2010, 48, 45.
R. K. Trivedi, M. C. Patel, S. B. Jadhav, Sci. Pharm. 2011, 79, 525.
The United States Pharmacopoeia 45 and National Formulary 40, US Pharmacopoeial Convention, Rockville, US Pharmacopoeial Convention, Rockville, USA, 2022.
S. Riahi, F. Hadiloo, S. M. R. Milani, N. Davarkhah, M. R. Ganjali, P. Norouzi, P. Seyfi, Drug Test Anal. 2011, 3, 319.
M. Ebrahimi, M. R. Sohrabi, F. Motiee, M. Davallo, Optik 2021, 230, 166323.
N.B. Pappano, Y.C. De Micalizzi, N.B. Debattista, F.H. Ferretti, Talanta 1997,44, 633.
H. M. Maher, M. M. Alshehri, S. M. Al-Taweel, Luminescence 2015, 30, 330.
S. M. Amer, S. S. Abbas, M. A. Shehata, N. M. Ali, J. AOAC Int. 2008, 91, 276.
J. Aluri, S. Stavchansky, J. Pharm. Biomed. Anal. 1993, 11, 803.
M. H. Sharaf, D. D. Stiff, J. Pharm. Biomed. Anal. 2004, 35, 801.
S. S. Abd El-Hay, R. El Sheikh, M. Ali, A. A. Gouda, H. M. El-Sayed, Talanta 2023, 8, 100233.
H. Beitollahi, K. Movlaee, M. R. Ganjali, P. Norouzi, R. Hosseinzadeh, Appl. Organomet. Chem. 2018, 32, 4243.
I. Tapsoba, J.-E. Belgaied, K. Boujlel, J. Pharm. Biomed. Anal. 2005, 38, 162.
J. Seagrave, H. H. Albrecht, D. B. Hill, D. F. Rogers, Respir. Res. 2012, 13, 1.
Y. T. Lin, H. S. Kou, H. L. Wu, Electrophoresis 2008, 2008(29), 3524.
J. K. Jain, M. Prakash, R. K. Mishra, A. P. Khandhar, Pak. J. Pharm. Sci. 2008, 2, 2, 21.
R. V. Rele, Der Pharm. Lett. 2015, 7, 154.
M. A. Tantawy, A. M. Yehia, H. Y. Aboul-Enein, Chirality 2019, 31, 835.
P. M. Njaria, K. O. Abuga, F. N. Kamau, H. K. Chepkwony, Chromatographia 2016, 79, 1507.
N. Itagimatha, D. Manjunatha, Ann. Pharm. Fr. 2019, 77, 295.
M. M. Abdelrahman, N. S. Abdelwahab, Anal. Methods 2014, 6, 509.
R. Kimbahune, K. Sunil, P. Kabra, K. Delvadiya, S. Surani, Int. J.Pharm. Sci. Rev. Res. 2011, 8, 24.
N. K. Gill, G. Sarma, A. Thakkar, J. Chil. Chem.Soc. 2012, 57, 1436.
S. A. Boltia, A. S. Fayed, M. A. Hegazy, J. Pharm. Res. 2018, 12, 7.
ICH, Harmonised Tripartite Guidelines, Validation of analytical procedures: text and methodology Q2 (R1). Current Step 4 Version, Parent Guidelines on Methodology Dated November 6, 1996, Incorporated in November 2005.
M. Tobiszewski, M. Marc, A. Gałuszka, J. Namiesnik, Molecules 2015, 20, 10928.
A. Gałuszka, Z. M. Migaszewski, P. Konieczka, J. Namieśnik, Anal. Chem. 2012, 37, 61.
J. Płotka-Wasylka, Talanta 2018, 181, 204.
H. T. S. Britton, R. A. Robinson, CXCVIII. J. Chem. Soc. 1931, 0, 1456.
C. Y. Huang, Meth. Enzymol. 1982, 87, 87, 509.
N. A. Vodolazkaya, Y. A. Gurina, N. V. Salamanova, N. O. Mchedlov-Petrossyan, J. Mol. Liq. 2009, 145, 188.
https://go.drugbank.com/ (assessed on 1/9/2022).
J.R. Lakowicz, Springer, 2006.
X. Wang, P. Wu, Y. Lv, X. Hou, Microchem. J. 2011, 99, 327.
Q. Wu, C. Li, Y. Hu, Y. Liu, Sci. China Ser. B: Chem. 2009, 52, 2205.
N. Boens, W. Qin, N. Basarić, J. Hofkens, M. Ameloot, J. Pouget, J.-P. Lefevre, B. Valeur, E. Gratton, M. Vandeven, Anal. Chem. 2007, 79, 2137.
S. Bi, L. Ding, Y. Tian, D. Song, X. Zhou, X. Liu, H. Zhang, J. Mol. Struct. 2004, 703, 37.
P. D. Ross, S. Subramanian, Biochemistry 1981, 20, 3096.
R. Chang, J.W. Thoman, Physical chemistry for the chemical sciences, Royal Society of Chemistry, Herndon, USA 2014.
A. K. Bronowska, Intech Open 2011, 4.
L. L. Guo, X. Ma, J. Yan, K. Xu, Q. Wang, H. Li, J. Fluoresc. 2015, 25, 1681.
J. Miller, J.C. Miller, Statistics and chemometrics for analytical chemistry, Pearson Education Limited, Harlow, England, 2018.
P.B. Toxic, Chemicals Covered by the TRI program, The United States Environmental Protection Agency, Washington, USA, 2022 https://www.Epa.Gov/toxicsrelease-inventory-tri-program/persistent-bioaccumulative-toxic-pbt-chemicalscovered-tri [Accessed 18 April 2022]
J. Griffith, R. C. Duncan, W. B. Riggan, A. C. Pellom, Pollut. Arch. Int.J. Environ. Health Res. 1989, 44, 69.
M. de la Guardia, J. Ruzicka, Analyst 1995, 120, 17N.
M. de La Guardia, K. D. Khalaf, V. Carbonell, A. Morales-Rubio, Anal. Chim. Acta 1995, 308, 462.

Auteurs

Ghidaa G Elawadi (GG)

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

Fawzi Elsebaei (F)

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

Mona E Fathy (ME)

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

Mohammed E-S Metwally (ME)

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

Classifications MeSH