Science Journal of Analytical Chemistry

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Quality Control by HPLC of Azithromycin Specialties Marketed in Ivory Coast During COVID-19

Received: 20 November 2023    Accepted: 19 December 2023    Published: 8 January 2024
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Abstract

Azithromycin is an antibiotic of the macrolide subclass. Ivory Coast, in its strategy to combat the Covid-19 pandemic, has developed a treatment protocol including azithromycin. Faced with the high consumption of this molecule in the Covid-19 period and with the aim of fighting against substandard drugs, this work was undertaken in order to validate an HPLC method for the dosage of AZT and the search for its degradation products. The validated method was carried out on an octadecylsylanized column (250 mm × 4.6 mm, 5 μm) using a mobile phase which consisted of a methanol/phosphate buffer mixture at pH 7.5 (80/20 v/v). The flow rate was set at 1.5 ml/min for a column temperature of 50°C and the UV detection wavelength at 210 nm. Forced degradation studies were carried out under the conditions: acidic, alkaline, oxidizing, UV light and thermal, in order to determine the degradation profiles. The validation parameters which are the linearity domain, the limits of detection and quantification; repeatability and accuracy were satisfactory. All samples showed consistent azithromycin contents. However, related substances and degradation products have been found in certain specialties. The validation of the HPLC method gave reliable results which allowed the determination of AZT and the search for degradation products and impurities.

DOI 10.11648/j.sjac.20241101.11
Published in Science Journal of Analytical Chemistry (Volume 12, Issue 1, April 2024)
Page(s) 1-6
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

COVID-19, Azithromycin, Validation, HPLC, Degradation Products

References
[1] World Health Organization, "COVID-19 – Timeline of WHO action”. Available on: https://www.who.int/fr/news/item/27-04-2020-who-timeline---covid-19. [Accessed October 20, 2023].
[2] Ledevoir, “Follow the spread of COVID-19 around the world”. Available at: https://www.ledevoir.com/documents/special/20-03_covid19-carte-dynamic/index.html. [Consulted on November 1, 2023].
[3] Ministry of Health and Public Hygiene of Côte d'Ivoire. Directive relating to the care and protection of health personnel in the context of COVID-19 disease, Directive No. 0875 of March 20, 2020.
[4] Johnston, S. L. Macrolide antibiotics and asthma treatment. Journal of Allergy and Clinical Immunology. 2006, 117(6), 1233-1236. DOI: 10.1016/j.jaci.2006.03.035
[5] Matzneller, P., Krasnigi, S., Kinzig, M., Sörgel, F., Hüttner, S., Lackner, E., Müller, M., Zeitlinge, M. Blood, tissue, and intracellular concentrations of azithromycin during and after end of therapy. Antimicrobial Agents and Chemotherapy. 2013, 57 (4), 1736-1742. DOI: 10.1128/AAC.02011-12.
[6] Anfel, S., Mohamed, B., Benmatti, H. Degradation of azithromycin from aqueous solution by oxidation of ferrous chlorine: ANN-GA modeling and evaluation of Daphnia magna biotoxicity tests. Environmental Research. 2022, 214 (3) DOI: 10.1016/j.envres.2022.114026.
[7] Pimay, G., Dantier, B., Tourid, W., Terkemani, A. and al. Beneficial effect of the hydroxychloroquine/azithromycin combination in the treatment of elderly patients with COVID-19: results of an observational study. The Hospital Pharmacist and Clinician. 2020, 55(4), 398–403. DOI: 10.1016/j.phclin.2020.06.001.
[8] Waleed, K., and Aref, A. Azithromycin promising medicine for COVID 19 in early stage by effecting on mTOR and immune system. 2020 DOI: 10.13140/RG.2.2.17918.33608 available at https://www.researchgate.net/publication/340448998
[9] Vanzeler, M. L. A., Andrade, F., Soares, I. A. G., Sávio, K. C. D., Gonçalves, L. S., Paes, M. R. S. Use of azithromycin to treat Covid-19: a critical perspective. Revista Scientist Multidisciplinar Nucleo do Conhecimento. 2021, 9(4), 5-21. Available at https://www.nucleodoconhecimento.com.br/sante/usage-de-lazithromycine
[10] Oldenburg, C. E., Pinsky, B. A., Brogdon, J., Chen, C., Ruder, K. and al. “Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. Randomized Controlled Trial. 2021, 326 (6), 490-498. DOI: 10.1001/jama.2021.11517.
[11] Gautret, P., Lagier, J. C., Parola, P., Hoang, V. T., Meddeb, L., et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International journal of antimicrobial agents. 2020, 56(1), 01-06. DOI: 10.1016/j.ijantimicag.2020.105949.
[12] Rosenberg, E., Dufort, E. M., Udo, T. Association of treatment with hydroxychloroquine or azithromycin with in-hospital mortality in patients with Covid-19 in New York State. JAMA. 2020, 323(24), 2493-2502. DOI: 10.1001/jama.2020.8630.
[13] Yamama, Z. A., Mohammed, Y. A., Saevan, S. A. Comparison of Azithromycin Toxicity in Chickens and Quails. Iranian Journal of Veterinary Medicine. 2023, 17(4), 321-332. DOI: 10.32598/IJVM.17.4.1005354.
[14] Miao-qing, Z., Gui-Zhi, W., Jing-pu, Z., Chang-qin, H. The comparative analysis of gastrointestinal toxicity of azithromycin and 3′-decladinosyl azithromycin on zebrafish larvae. Toxicology and Applied Pharmacology. 2023,469,116529. DOI: 10.1016/j.taap.2023.116529.
[15] Lazhar, M., Tahani, E. A., Tir, M., Kadri, D. Azithromycin effects on the European sea bass ( Dicentrarchus labrax ) early life stages following acute and chronic exposure: Laboratory bioassays. Drug and Chemical Toxicology. 2020, 45(3), 1295-1301. DOI: 10.1080/01480545.2020.1822388.
[16] Shaimaa, A. E. M. I., Heba, A. E. B., Ola, M. G. Biodegradation of COVID19 antibiotic; azithromycin and its impact on soil microbial community in the presence of phenolic waste and with temperature variation. World Journal Microbiol ogy Biotechnology. 2023, 39(6), 154. DOI: 10.1007/s11274-023-03591-7
[17] Monica, L., Vermillion, M., Ronald, S. T. Azithromycin sorption and biodegradation in a simulated California river system. Chemosphere. 2017, 190. DOI: 10.1016/j.chemosphere.2017.10.008
[18] Cizmic, M., Ljubas, D., Rožman, M., Ašperger, D., Curkovic, L., Babi, S. Photocatalytic Degradation of Azithromycin by Nanostructured TiO2 Film: Kinetics, Degradation Products, and Toxicity. Journal Materials. 2019, 12(6), 873. DOI: 10.3390/ma12060873
[19] Yuping, Y., Fan, Li-jie., Cui, B., Genxiang, C., Zhenwei, Z., Cunlin, Z. The Study on the Far-FTIR and THz Spectra of Azitromycin Drugs with Different Physical Forms. Guang pu xue yu guang pu fen xi. 2015, 35(11), 3054-3057. Available at: https://europepmc.org/article/med/26978907
[20] Kwiecien, A., Krzek, J., Walczak, M. Stress degradation studies on azithromycin and development of a validated stability-indicating TLC-Densitometric Method with HPLC/Electrospray Ionization-MS analysis of degradation products. Journal of AOAC International. 2012, 95(5), DOI: 10.5740/jaoacint.10-196
[21] Zhang, G. R., Wang, X. L., Liu, Z. X., Zhuang, Q. Y. Voltammetric behavior of azitromycin. Chinese Journal of Analytical Chemistry. 2000, 28(1). Available at https://www.researchgate.net/publication/286463555
[22] Fuad, A. R., Maher, K. Analysis of azithromycin and its related compounds by RP-HPLC with UV detection. Journal of Chromatographic Science. 2010, 48(2), 86-90. DOI: 10.1093/ chromsci /48.2.86
[23] Attjioui, H. Stability study and dosage of Amoxicillin degradation products by high performance liquid chromatography in an Oral pharmaceutical form. Memory, Mohammed V University - Rabat Faculty of Medicine and Pharmacy, 2021.
[24] Marilly, E., Marchand, C., S almon, D., Dhelens, C., Filali, S., Merienne, C., Pirot, F., Pivot, C. Development and validation of a clomiphene citrate assay method for the stability study of an experimental drug. 2019. Available at https://www.gerpac.eu/ accessed October 18, 2023.
[25] ICH Harmonized Tripartite, 2005. Validation of analytical procedures: text and methodology. ICH Expert Working Group. 2005, 13p.
[26] Fiese, E. F., and Steffen, S. H. Comparison of the acid stability of azithromycin and. erythromycin. J. Antimicrob. Chemother. 1990, 25 (suppl. A): 39–47. DOI: 10.1093/ jac /25.suppl_a.39.
[27] US PHARMACOPEIA, National Formulary 41. 46th Edition, (2023), Volume 1.
[28] Mostafa, F. A. Rapid, developed and validated RP-HPLC method for determination of azithromycin. Springer Nature Applied Sciences. 2019, 1(222). DOI: 10.1007/S42452-019-0237-6.
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    Yao, M. A., Kpaibe, A. S., Yao, T. J. S., Able, N., Bony, N., et al. (2024). Quality Control by HPLC of Azithromycin Specialties Marketed in Ivory Coast During COVID-19. Science Journal of Analytical Chemistry, 12(1), 1-6. https://doi.org/10.11648/j.sjac.20241101.11

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    ACS Style

    Yao, M. A.; Kpaibe, A. S.; Yao, T. J. S.; Able, N.; Bony, N., et al. Quality Control by HPLC of Azithromycin Specialties Marketed in Ivory Coast During COVID-19. Sci. J. Anal. Chem. 2024, 12(1), 1-6. doi: 10.11648/j.sjac.20241101.11

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    AMA Style

    Yao MA, Kpaibe AS, Yao TJS, Able N, Bony N, et al. Quality Control by HPLC of Azithromycin Specialties Marketed in Ivory Coast During COVID-19. Sci J Anal Chem. 2024;12(1):1-6. doi: 10.11648/j.sjac.20241101.11

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  • @article{10.11648/j.sjac.20241101.11,
      author = {Marcelle Adjoa Yao and Andre Sawa Kpaibe and Thodhekes Jean Simon Yao and Nina Able and Nicaise Bony and Christophe Amin and Michèle Aké},
      title = {Quality Control by HPLC of Azithromycin Specialties Marketed in Ivory Coast During COVID-19},
      journal = {Science Journal of Analytical Chemistry},
      volume = {12},
      number = {1},
      pages = {1-6},
      doi = {10.11648/j.sjac.20241101.11},
      url = {https://doi.org/10.11648/j.sjac.20241101.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20241101.11},
      abstract = {Azithromycin is an antibiotic of the macrolide subclass. Ivory Coast, in its strategy to combat the Covid-19 pandemic, has developed a treatment protocol including azithromycin. Faced with the high consumption of this molecule in the Covid-19 period and with the aim of fighting against substandard drugs, this work was undertaken in order to validate an HPLC method for the dosage of AZT and the search for its degradation products. The validated method was carried out on an octadecylsylanized column (250 mm × 4.6 mm, 5 μm) using a mobile phase which consisted of a methanol/phosphate buffer mixture at pH 7.5 (80/20 v/v). The flow rate was set at 1.5 ml/min for a column temperature of 50°C and the UV detection wavelength at 210 nm. Forced degradation studies were carried out under the conditions: acidic, alkaline, oxidizing, UV light and thermal, in order to determine the degradation profiles. The validation parameters which are the linearity domain, the limits of detection and quantification; repeatability and accuracy were satisfactory. All samples showed consistent azithromycin contents. However, related substances and degradation products have been found in certain specialties. The validation of the HPLC method gave reliable results which allowed the determination of AZT and the search for degradation products and impurities.
    },
     year = {2024}
    }
    

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    T1  - Quality Control by HPLC of Azithromycin Specialties Marketed in Ivory Coast During COVID-19
    AU  - Marcelle Adjoa Yao
    AU  - Andre Sawa Kpaibe
    AU  - Thodhekes Jean Simon Yao
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    AU  - Michèle Aké
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    T2  - Science Journal of Analytical Chemistry
    JF  - Science Journal of Analytical Chemistry
    JO  - Science Journal of Analytical Chemistry
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    EP  - 6
    PB  - Science Publishing Group
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    UR  - https://doi.org/10.11648/j.sjac.20241101.11
    AB  - Azithromycin is an antibiotic of the macrolide subclass. Ivory Coast, in its strategy to combat the Covid-19 pandemic, has developed a treatment protocol including azithromycin. Faced with the high consumption of this molecule in the Covid-19 period and with the aim of fighting against substandard drugs, this work was undertaken in order to validate an HPLC method for the dosage of AZT and the search for its degradation products. The validated method was carried out on an octadecylsylanized column (250 mm × 4.6 mm, 5 μm) using a mobile phase which consisted of a methanol/phosphate buffer mixture at pH 7.5 (80/20 v/v). The flow rate was set at 1.5 ml/min for a column temperature of 50°C and the UV detection wavelength at 210 nm. Forced degradation studies were carried out under the conditions: acidic, alkaline, oxidizing, UV light and thermal, in order to determine the degradation profiles. The validation parameters which are the linearity domain, the limits of detection and quantification; repeatability and accuracy were satisfactory. All samples showed consistent azithromycin contents. However, related substances and degradation products have been found in certain specialties. The validation of the HPLC method gave reliable results which allowed the determination of AZT and the search for degradation products and impurities.
    
    VL  - 12
    IS  - 1
    ER  - 

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Author Information
  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast; Drug Control Laboratory, National Public Health Laboratory, Abidjan, Ivory Coast

  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast

  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast

  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast

  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast; Drug Control Laboratory, National Public Health Laboratory, Abidjan, Ivory Coast

  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast

  • Department of Analytical Chemistry and Bromatology, Felix Houphouët Boigny University, Abidjan, Ivory Coast

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