Design and implementation of green chemistry approaches into pharmaceutical analysys of benzydamine dosage formes

Authors

DOI:

https://doi.org/10.15587/2519-4852.2019.182024

Keywords:

green chemistry, benzidamine, liquid chromatography, gas chromatography, absorption spectrophotometry

Abstract

Aim. The development of the pharmaceutical industry of Ukraine and the world has led to an increase in the need for the use of hazardous and toxic chemicals and solvents, which affects the safety of the environment and directly employees of pharmaceutical companies.

Therefore, one of the solutions to this problem is the implementation of “green chemistry” approaches in pharmaceutical quality control laboratories.

Materials and methods. Chromatographic separation methods are used for the qualitative and quantitative analysis of raw materials and finished dosage forms, the determination of substances that are formed during the degradation of active substances and allow rapid analysis of complex mixtures.

Results. For the implementation of green chemistry principles in the laboratory of pharmaceutical companies, it is necessary to evaluate the possibility of using rapid quality control methods such as gas chromatography, ultra-high performance liquid chromatography, and absorption spectrophotometry in the ultraviolet and visible regions.

Conclusions. Approaches to "greening" of analytical procedures used in quality control of pharmaceuticals have been studied. Ways of implementation of modern approaches of methods of "green chemistry" to chromatographic methods are offered. On the basis of the developed decision tree the design of development and "greening" of the methods of quality control of benzidamine dosage forms is proposed

Author Biographies

Vasyl Chornyi, JSC «Farmak» Kirilivska str., 63, Kyiv, Ukraine, 04080

Head of Laboratory

Liquid dosage forms R&D laboratory

Vasyl Kushniruk, JSC «Farmak» Kirilivska str., 63, Kyiv, Ukraine, 04080

PhD, Head of Department
API Department

Victoriya Georgiyants, National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Professor, Head of Department

Department of Pharmaceutical Chemistry

References

  1. UNIDO (2018). The Stockholm Convention on Persistent Organic Pollutants (POPS) (2017). Texts and annexes revised in 2017. Stockholm, 78.
  2. Kreston GCG (2019). Investing in Health: Setting Up a Pharmaceutical Business, 24.
  3. Kupiec, T. (2004). Quality control Analytical Methods: high-performance liquid chromatography. International Journal of Pharmaceutical Compounding, 8 (3), 233–237.
  4. Siddiqui, M. R., Alothman, Z. A., Rahman, N. (2017). Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of Chemistry, 10, S1409–S1421. doi: http://doi.org/10.1016/j.arabjc.2013.04.016
  5. Khan, I., Mulpuri, K., Das, B., Mohiuddin, M. D., Rahman, M. H. Ur. (2015). Analytical Techniques (Chromatography, Spectroscopy, Electrophorosis) In Pharmaceutical Analysis: A Review. International Journal of Research in Pharmaceutical and Nano Sciences, 4 (1), 19–27.
  6. NewSEP (2016). Regulation of the market for medicinal products in Ukraine: problems and solutions, 113.
  7. Korany, M. A., Mahgoub, H., Haggag, R. S., Ragab, M. A. A., Elmallah, O. A. (2017). Green chemistry: Analytical and chromatography. Journal of Liquid Chromatography & Related Technologies, 40 (16), 839–852. doi: http://doi.org/10.1080/10826076.2017.1373672
  8. Anastas, P. T., Warner, J. C. (1998). Principles of Green Chemistry, Green Chemistry Theory and Practice. New York: Oxford University Press, 152.
  9. Manley, J. B., Anastas, P. T., Cue, B. W. (2008). Frontiers in Green Chemistry: meeting the grand challenges for sustainability in R&D and manufacturing. Journal of Cleaner Production, 16 (6), 743–750. doi: http://doi.org/10.1016/j.jclepro.2007.02.025
  10. Anastas, P. T. (1999). Green Chemistry and the Role of Analytical Methodology Development. Critical Reviews in Analytical Chemistry, 29 (3), 167–175. doi: http://doi.org/10.1080/10408349891199356
  11. Namiesnik, J. (1999). Pro-Ecological education. Environmental Science and Pollution Research, 6 (4), 243–244. doi: http://doi.org/10.1007/bf02987339
  12. Samanidou, V. F. (2014). Pharmaceutical Analysis from a Green Perspective. Austin Journal of Analytical and Pharmaceutical Chemistry, 1 (4), 1016.
  13. Koel, M., Kaljurand, M. (2006). Application of the principles of green chemistry in analytical chemistry. Pure and Applied Chemistry, 78 (11), 1993–2002. doi: http://doi.org/10.1351/pac200678111993
  14. Gałuszka, A., Migaszewski, Z., Namieśnik, J. (2013). The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices. TrAC Trends in Analytical Chemistry, 50, 78–84. doi: http://doi.org/10.1016/j.trac.2013.04.010
  15. Talaviya, S., Majmudar, F. (2012). Green Chemistry: A Tool in Pharmaceutical Chemistry. NHL Journal of Medical Sciences, 1 (1), 7–13.
  16. Akseli, I., Mani, G. N., Cetinkaya, C. (2008). Non-destructive acoustic defect detection in drug tablets. International Journal of Pharmaceutics, 360 (1-2), 65–76. doi: http://doi.org/10.1016/j.ijpharm.2008.04.019
  17. Ahuja, S.; Ahuja, S., Jespersen, N. (Eds.) (2006). High Pressure Liquid Chromatography. Comprehensive Analytical Chemistry, 47, 485–559.
  18. Lindholm, J. (2004). Development and Validation of HPLC Methods for Analytical and Preparative Purposes. Acta Universitatis Upsaliensis. Comprehensive Summaries of Uppsala Dissertations from the Faculty of Science and Technology 995, 87.
  19. Nledner, W., Karsten, M., Stelner, F., Swart, R. (2008). Automating Method Development with an HPLC System Optimized for Scouting of Columns, Eluents and Other Method Parameters. Pittcon Presentation.
  20. Byrne, F. P., Jin, S., Paggiola, G., Petchey, T. H. M., Clark, J. H., Farmer, T. J. et. al. (2016). Tools and techniques for solvent selection: green solvent selection guides. Sustainable Chemical Processes, 4 (1). doi: http://doi.org/10.1186/s40508-016-0051-z
  21. Dogan, A., E. Bascı, N. (2011). Development and Validation of RP-HPLC and Ultraviolet Spectrophotometric Methods of Analysis for the Quantitative Determination of Chlorhexidine Gluconate and Benzydamine Hydrochloride in Pharmaceutical Dosage Forms. Current Pharmaceutical Analysis, 7 (3), 167–175. doi: http://doi.org/10.2174/157341211796353228
  22. British Pharmacopeia. Vol. 3, 181.
  23. Dinç Zor, Ş., Aksu Dönmez, Ö. (2018). A Facile HPLC-PDA Method for Simultaneous Determination of Paracetamol, Methyl Paraben, Sunset Yellow and Carmosine in Oral Suspensions. Journal of the Turkish Chemical Society, Section A: Chemistry, 763–774. doi: http://doi.org/10.18596/jotcsa.403497
  24. Levchyk, V., Zui, M. (2015). Gas Chromatographic determination of parabens after derivatization and dispersive microextraction. French-Ukrainian Journal of Chemistry, 3 (2), 72–79. doi: http://doi.org/10.17721/fujcv3i2p72-79
  25. Carlucci, G., Iuliani, P., Di Federico, L. (2010). Simultaneous Determination of Benzydamine Hydrochloride and Five Impurities in an Oral Collutory as a Pharmaceutical Formulation by High-Performance Liquid Chromatography. Journal of Chromatographic Science, 48 (10), 854–859. doi: http://doi.org/10.1093/chromsci/48.10.854

Downloads

Published

2019-10-31

How to Cite

Chornyi, V., Kushniruk, V., & Georgiyants, V. (2019). Design and implementation of green chemistry approaches into pharmaceutical analysys of benzydamine dosage formes. ScienceRise: Pharmaceutical Science, (5 (21), 12–17. https://doi.org/10.15587/2519-4852.2019.182024

Issue

No. 5 (21) (2019)

Section

Pharmaceutical Science

License

Copyright (c) 2019 Vasyl Chornyi, Vasyl Kushniruk, Victoriya Georgiyants

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Our journal abides by the Creative Commons Attribution 4.0 International License copyright rights and permissions for open access journals.

Authors, who are published in this journal, agree to the following conditions:

1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons Attribution 4.0 International License, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.

 2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.

3. Authors have the right to store the final accepted version of the article in an institutional, thematic, or any other repository to ensure visibility and accessibility.