Research Article | | Peer-Reviewed

A Novel Analytical Method for Determining a Combination of Tetrahydrozoline and Antazoline HCl by Modulating Ratio Spectra

Received: 8 August 2024     Accepted: 2 September 2024     Published: 26 September 2024
Views:       Downloads:
Abstract

In this study, the combination of pharmaceutical formulation of tetrahydrozline HCl (TZ) and antazoline HCl (AN) was determined without separating them using smart analytical UV spectrophotometric methods. While the Extended Ratio Subtraction Method (EXRSM) is used to determine AN, the Ratio Subtraction Method (RSM) is utilized to determine TZ and is linked with the ratio subtraction technique. The calibration curves for AN and TZ are linear, ranging from 3.0 to 30.0 µg/mL and 5.0 to 45.0 µg/mL, respectively. Analyzing several laboratory-prepared combinations of the two medications allowed researchers to assess the specificity of the designed methods. The selected drugs' combined dosage form was determined with success using both approaches. Validation was carried out in accordance with ICH requirements, and it was found that repeatability, accuracy, and intermediate precision were all within acceptable limits. Statistical studies showed that both methods can be competitively applied in quality control laboratories. RSM and the EXRSM are complementary to one another, as shown by the determination of AN and TZ without pre-separation. Without any prior separation, the EXRSM was able to differentiate between substances with an extended spectrum using the same characteristics. Therefore, one alternative approach to liquid chromatography techniques is the combination of EXRSM and RSM.

Published in Science Journal of Analytical Chemistry (Volume 12, Issue 2)
DOI 10.11648/j.sjac.20241202.12
Page(s) 24-32
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Antazoline, Tetrahydrozoline, Ratio Subtraction, Extended Ratio Subtraction, Spectrophotometry

References
[1] Abelson, MB., Allansmith, MR., Friedlaender, MH. Effects of topically applied occular decongestant and antihistamine. Am J Ophthalmol. 1980, 90(2), 254-257.
[2] British Pharmacopoeia Commission, British Pharmacopoeia 2019. London: TSO; 2019, pp. 188, 1125.
[3] Milhaud, D., Fagni, L., Bockaert, J., Lafon-Cazal, M. Inhibition of voltage-gated Ca2+ channels by antazoline. Neuroreport, 2002, 13(14), 1711-1714.
[4] Abdel-Halim, LM., Abd-El Rahman, MK., Ramadan, NK., El Sanabary, HFA., Salem, MY. Comparative study between recent methods manipulating ratio spectra and classical methods based on two-wavelength selection for the determination of binary mixture of antazoline hydrochloride and tetryzoline hydrochloride. Spectrochim Acta A Mol Biomol Spectrosc, 2016, 159: 98-105.
[5] Castillo, M., Scott, NW., Mustafa, MZ., Mustafa, MS., Azuara-Blanco, A. Topical antihistamines and mast cell stabilisers for treating seasonal and perennial allergic conjunctivitis. Cochrane Database Syst Rev, 2015(6).
[6] Maryadele, JJI., Whitehouse station, NJ, USA, The Merck Index, Merck research laboratories, Merck & Co. 2006. pp. 5768.
[7] Lowry, J., Brown JTJCT. Significance of the imidazoline receptors in toxicology. Clin Toxicol (Phila), 2014, 52(5), 454-469.
[8] Cuvillo, A., Sastre, J., Montoro, J., Jáuregui, I., Dávila, I., Ferrer, M., Bartra, J., Mullol, J., Valero, A. Allergic Conjunctivitis and H1 Antihistamines. J Investig Allergol Clin Immunol. 2009, 19(1), 11-18.
[9] McLaurin, E., Cavet, ME., Gomes, PJ., Ciolino, JB. Brimonidine ophthalmic solution 0.025% for reduction of ocular redness: a randomized clinical trial. Optom Vis Sci. 2018, 95(3), 264-271.
[10] Bekele, A., Hymete, A., Bekhit, A. Development and validation of HPTLC densitometric method for simultaneous determination of antazoline hydrochloride and tetryzoline hydrochloride in eye drop and its application as stability indicator. Thai J Pharm Sci, 2013, 37(3), 134-145.
[11] Puglisi, G., Sciuto, S., Chillemi, R., Mangiafico, S. Simultaneous high-performance liquid chromatographic determination of antazoline phosphate and tetrahydrozoline hydrochloride in ophthalmic solution. J. Chromatogr A, 1986, 369, 165-170.
[12] Kountourellis, JE., Raptouli, A. Simultaneous determination of 2-imidazolines and other pharmaceutical substances in commercial preparations by high-performance liquid-chromatography. Analytical Letters, 1988, 21(8), 1361–1370.
[13] Shadoul, WA., Kariem, EAG., Ibrahim, KEE., Adam, ME. Simultaneous determination of tetrahydrozoline hydrochloride and antazoline hydrochloride in ophthalmic solutions using HPLC. Asian J Pharm Sci and Res, 2011, 1, 29–38.
[14] De Schutter, JA., Bossche, WV., Moerloose, PD. Stability-indicating analysis of tetryzoline hydrochloride in pharmaceutical formulations by reversed-phase ion-pair liquid chromatography. J Chromatogr, 1987, 391(1), 303-308.
[15] Andermann, G., Richard, A. Stability-indicating determination of tetrahydrozoline hydrochloride in ophthalmic solutions by high-performance liquid chromatography. J Chromatogr, 1984, 298(1), 189-192.
[16] Lotfy, HM., Hegazy, MA. Comparative study of novel spectrophotometric omeprazole, tinidazole and clarithromycin. Spectrochim Acta A Mol Biomol Spectrosc, 2012, 96, 259-270.
[17] El-Bardicy, MG., Lotfy, HM., El-Sayed, MA., El-Tarras, MF. Smart stability-indicating spectrophotometric methods for determination of binary mixtures without prior separation. J AOAC Int, 2008, 91(2), 299-310.
[18] Essam, HM., Abd-El Rahman, MK. Smart manipulation of ratio spectra for resolving a pharmaceutical mixture of Methocarbamol and Paracetamol. Spectrochim Acta A Mol Biomol Spectrosc, 2015, 141, 1-9.
[19] Moffat, AC., Clarke, EGC. Clarke’s analysis of drugs and poisons: in pharmaceuticals, body fluids and postmortem material, Pharmaceutical Press, London, 2011.
[20] Lotfy, HM., Hegazy MA. Simultaneous determination of some cholesterol-lowering drugs in their binary mixture by novel spectrophotometric methods. Spectrochim Acta A Mol Biomol Spectrosc, 2013, 113, 107-114.
[21] Spiegel, MR., Stephen, JL. Theory and problems of statistics, 4TH Edition, 2008: 275-279.
Cite This Article
  • APA Style

    Elhalim, L. M. A., Ramadan, N. K., El Rahman, M. K. A., Galal, M. M. (2024). A Novel Analytical Method for Determining a Combination of Tetrahydrozoline and Antazoline HCl by Modulating Ratio Spectra. Science Journal of Analytical Chemistry, 12(2), 24-32. https://doi.org/10.11648/j.sjac.20241202.12

    Copy | Download

    ACS Style

    Elhalim, L. M. A.; Ramadan, N. K.; El Rahman, M. K. A.; Galal, M. M. A Novel Analytical Method for Determining a Combination of Tetrahydrozoline and Antazoline HCl by Modulating Ratio Spectra. Sci. J. Anal. Chem. 2024, 12(2), 24-32. doi: 10.11648/j.sjac.20241202.12

    Copy | Download

    AMA Style

    Elhalim LMA, Ramadan NK, El Rahman MKA, Galal MM. A Novel Analytical Method for Determining a Combination of Tetrahydrozoline and Antazoline HCl by Modulating Ratio Spectra. Sci J Anal Chem. 2024;12(2):24-32. doi: 10.11648/j.sjac.20241202.12

    Copy | Download

  • @article{10.11648/j.sjac.20241202.12,
      author = {Lamia Mohammed Abd Elhalim and Nesrin Khamis Ramadan and Mohammed Khaled Abd El Rahman and Maha Mohammed Galal},
      title = {A Novel Analytical Method for Determining a Combination of Tetrahydrozoline and Antazoline HCl by Modulating Ratio Spectra
    },
      journal = {Science Journal of Analytical Chemistry},
      volume = {12},
      number = {2},
      pages = {24-32},
      doi = {10.11648/j.sjac.20241202.12},
      url = {https://doi.org/10.11648/j.sjac.20241202.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20241202.12},
      abstract = {In this study, the combination of pharmaceutical formulation of tetrahydrozline HCl (TZ) and antazoline HCl (AN) was determined without separating them using smart analytical UV spectrophotometric methods. While the Extended Ratio Subtraction Method (EXRSM) is used to determine AN, the Ratio Subtraction Method (RSM) is utilized to determine TZ and is linked with the ratio subtraction technique. The calibration curves for AN and TZ are linear, ranging from 3.0 to 30.0 µg/mL and 5.0 to 45.0 µg/mL, respectively. Analyzing several laboratory-prepared combinations of the two medications allowed researchers to assess the specificity of the designed methods. The selected drugs' combined dosage form was determined with success using both approaches. Validation was carried out in accordance with ICH requirements, and it was found that repeatability, accuracy, and intermediate precision were all within acceptable limits. Statistical studies showed that both methods can be competitively applied in quality control laboratories. RSM and the EXRSM are complementary to one another, as shown by the determination of AN and TZ without pre-separation. Without any prior separation, the EXRSM was able to differentiate between substances with an extended spectrum using the same characteristics. Therefore, one alternative approach to liquid chromatography techniques is the combination of EXRSM and RSM.
    },
     year = {2024}
    }
    

    Copy | Download

  • TY  - JOUR
    T1  - A Novel Analytical Method for Determining a Combination of Tetrahydrozoline and Antazoline HCl by Modulating Ratio Spectra
    
    AU  - Lamia Mohammed Abd Elhalim
    AU  - Nesrin Khamis Ramadan
    AU  - Mohammed Khaled Abd El Rahman
    AU  - Maha Mohammed Galal
    Y1  - 2024/09/26
    PY  - 2024
    N1  - https://doi.org/10.11648/j.sjac.20241202.12
    DO  - 10.11648/j.sjac.20241202.12
    T2  - Science Journal of Analytical Chemistry
    JF  - Science Journal of Analytical Chemistry
    JO  - Science Journal of Analytical Chemistry
    SP  - 24
    EP  - 32
    PB  - Science Publishing Group
    SN  - 2376-8053
    UR  - https://doi.org/10.11648/j.sjac.20241202.12
    AB  - In this study, the combination of pharmaceutical formulation of tetrahydrozline HCl (TZ) and antazoline HCl (AN) was determined without separating them using smart analytical UV spectrophotometric methods. While the Extended Ratio Subtraction Method (EXRSM) is used to determine AN, the Ratio Subtraction Method (RSM) is utilized to determine TZ and is linked with the ratio subtraction technique. The calibration curves for AN and TZ are linear, ranging from 3.0 to 30.0 µg/mL and 5.0 to 45.0 µg/mL, respectively. Analyzing several laboratory-prepared combinations of the two medications allowed researchers to assess the specificity of the designed methods. The selected drugs' combined dosage form was determined with success using both approaches. Validation was carried out in accordance with ICH requirements, and it was found that repeatability, accuracy, and intermediate precision were all within acceptable limits. Statistical studies showed that both methods can be competitively applied in quality control laboratories. RSM and the EXRSM are complementary to one another, as shown by the determination of AN and TZ without pre-separation. Without any prior separation, the EXRSM was able to differentiate between substances with an extended spectrum using the same characteristics. Therefore, one alternative approach to liquid chromatography techniques is the combination of EXRSM and RSM.
    
    VL  - 12
    IS  - 2
    ER  - 

    Copy | Download

Author Information
  • Sections