Abstract
Chronic obstructive pulmonary disease is a major cause of morbidity and mortality worldwide. Combining an inhaled anticholinergic and a β2-agonist are a convenient way of delivering treatment, obtaining better lung function and improved symptoms. We aimed to develop and validate a reliable HPLC method for the simultaneous determination of the anticholinergics; ipratropium bromide, glycopyrronium bromide and tiotropium bromide in addition to the β2-agonists; bambuterol hydrochloride, formoterol fumarate and indacaterol maleate. The chromatographic separation was achieved on a Phenomenex Luna phenyl-hexyl (250 × 4.6 mm i.d., 5 μm) column and a mobile phase composed of 0.2% phosphoric acid (pH 3.0)/methanol/acetonitrile (66:12:22, v/v/v). The analysis was performed at a flow rate of 1 mL/min with UV detection at 210 nm. Method validation showed that calibration curves were linear within the range from 0.5 to 30.0 μg/mL with a correlation coefficient > 0.998. Intraday and interday precision and accuracy evaluated by relative standard deviation were lower than 2%. The limits of detection were in the ranges of 0.037–0.152 μg/mL. The developed method which is rapid, sensitive and highly efficient was applied for the analysis of the six bronchodilators in single and combined formulations saving money, solvents and chemicals. In addition, the environmental impact of the proposed method was evaluated using a suitable analytical Eco-Scale.
Similar content being viewed by others
References
A. Agusti, M. Decramer, R. Bartolome, R. Chen, G. Criner et al., Global Initiative for Chronic Obstructive Lung Disease (GOLD) 187, 6 (2017)
M. Decramer, W. Janssens, M. Miravitlles, Lancet 379, 1341 (2012)
F. Donohue, Proc Am Thorac Soc. 2, 272 (2005)
M. Cazzola, D.P. Tashkin, COPD 6, 404 (2009)
C.S. Ulrik, Int. J. COPD 7, 673 (2012)
M. Cazzola, C.P. Page, L. Calzetta, M.G. Matera, Pharmacol. Rev. 64, 450–504 (2012)
E.M. Hassan, J. Pharm. Biomed. Anal. 21, 1183 (2000)
W.E. Hassan, S.M. Eid, K.M. Kelani, A.A. Shalaby, Drug Invention Today 5, 2 (2013)
D. Taşkın, G. Erensoy, S. Sungur, Marmara Pharm. J. 20, 275 (2016)
M.F. Abdel Ghany, L.A. Hussein, N. Magdy, H.Z. Yamani, Spectrochim Acta A Mol Biomol Spectrosc 157, 251 (2016)
N.M. El-Abasawy, K.A. Attia, A.A. Abouserie, A. El-Olemy, A.O. Elsayed, Ejbps 5, 80 (2018)
H.M. Ahmed, B.J. Clark, J. Ion Exchange 18, 258 (2007)
S. Abo El Abass, H. Elmansi, R Soc Open Sci. 5, 181359 (2018)
D. Nebiu, M. Walter, B. Lachmann, H. Kopelent, C.R. Noe, Pharmazie 62, 406 (2007)
Y.M. Zhou, B. Zhou, Chin. J. Pharm. 46, 1327 (2015)
L. Bin, Chin. J. Pharm Anal. 31, 920 (2011)
P. Pavan Kalyan, M. Srikanth, M. Prasadarao, World J. Pharm. Pharm. Sci. 4, 759 (2015)
K. Srinivasu, J.V. Rao, N.A. Raju, K. Mukkanti, Asian J. Chem. 22, 3943 (2010)
S. Zayed, F. Belal, Chem Cent J. 11, 36 (2017)
R.K. Trivedi, D.S. Chendake, M.C. Patel, Sci. Pharm. 80, 591 (2012)
A.S. Nevse, S. Yadav, R.N. Purohit, J.R. Rao, World. J. Pharm. Pharm. Sci. 5, 795 (2016)
A.S. Patil, Int. J. Adv. Pharm. Anal. 5, 80 (2015)
S.M. Soliman, O.M. EL-Houssini, J Chromatogr Sci. 57, 799 (2019)
G.R. Murray, T.N. Calvey, N.E. Williams, K. Chan, J. Chromatogr B. 308, 143 (1984)
S.O. Akapo, M. Wegner, A. Mamangun, C. McCrea, M. Asif, J.C. Dussex, J Chromatogr A 1045, 211 (2004)
E. Senera, M. Tunçela, H.Y. Aboul-Enein, Arch. Pharm. Pharm. Med. Chem. 336, 226 (2003)
T. Güray, M. Tunçel, U.D. Uysal, J. Food Drug Anal. 26, 842 (2018)
S. Zayed, F. Belal, MCJ 155, 104779 (2020)
I. Tomaz, L. Maslov, Food Anal Methods 9, 401 (2016)
International Conference on Harmonization (ICH) (2005) Technical Requirements for the Registration of Pharmaceutical for Human Use, Validation of Analytical Procedures; Text and methodology Q2 (R1), Geneva, 1
J. Miller, J. Miller, Statistics and Chemometrics for Analytical Chemistry, 5thedn (Harlow, England, Pearson Education Limited, 2005), p. 256
A. Gałuszka, Z.M. Migaszewski, P. Konieczka, N. Snik, J. Trends Anal Chem 37, 61 (2012)
M. Tobiszewski, M. Marc, A. Galuszka, J. Namiesnik, Molecules 20, 10928 (2015)
J. Płotka-Wasylka, Talanta 181, 202 (2018)
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare no conflict of interest.
Rights and permissions
About this article
Cite this article
Zayed, S., Fouad, F. & Belal, F. A simple and economic chromatographic method for simultaneous determination of six bronchodilator drugs in pharmaceutical dosage forms. J IRAN CHEM SOC 18, 1251–1259 (2021). https://doi.org/10.1007/s13738-020-02107-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s13738-020-02107-6