Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC

Vasyl A. Cherniy; Svitlana N. Gureeva; Victoriya A. Georgiyants

doi:doi:10.11648/j.jddmc.20160206.12

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Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC

Vasyl A. Cherniy, Svitlana N. Gureeva, Victoriya A. Georgiyants

Published in Journal of Drug Design and Medicinal Chemistry (Volume 2, Issue 6)

Received: 20 October 2016 Accepted: 10 November 2016 Published: 10 January 2017

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Abstract

The aim of the present study was to develop and validate HPLC method for determination of related substances of benzydamine hydrochloride in a dosage form, containing benzydamine hydrochloride as an active substance. A new selective, specific and sensitive method was developed for determination of benzydamine degradation products in the formulation. Determination was carried out by reversed-phase HPLC using isocratic solvent elution. The method was validated and found to be precise, accurate and specific; the detector response was linear over 0,05% - 1.2% relative to the nominal concentration of benzydamine hydrochloride in the formulation. The developed HPLC method is useful for determination of benzydamine hydrochloride related substances in formulations and can be applied in Quality Control Laboratories.

Published in	Journal of Drug Design and Medicinal Chemistry (Volume 2, Issue 6)
DOI	10.11648/j.jddmc.20160206.12
Page(s)	65-73
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

Benzydamine Hydrochloride, HPLC Method, Related Substances, Chromatographic Separation

References

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[2]	Anand JS, Glebocka ML, Korolkiewicz RP. Recreational abuse with benzydamine hydrochloride (tantum rosa). // ClinToxicol (Phila). — 2007.
[3]	British Pharmacopeia Volume 3 p. 181.
[4]	Carlucci G. Simultaneous determination of benzydamine hydrochloride and five impurities in an oral collutory as a pharmaceutical formulation by high-performance liquid chromatography. G. Carlucci, P. Iuliani, L. Di Federico. // J Chromatogr Sci. 2010 Nov; 48 (10): 854-9.
[5]	Catanese B. HPLC determination of benzydamine and its metabolite N-oxide in plasma following oral administration or topical application in man, using fluorimetric detection.. //B. Catanese, A. Lagana A. Marino, R. Picollo, M. Rotatori. Pharmacol Res Commun. 1986 Apr; 18 (4): 385-403.
[6]	J. Wang and D. E. Moore. A study of the photodegradation of benzydamine in pharmaceutical formulations. J. Pharm. Biomed. Anal. 7: 535–540 (1992).
[7]	G. Carlucci and P. Mazzeo. High-performance liquid chromatographic determination of 1-benzyl-1H-indazol-3-ol in benzydamine in pharmaceutical formulations. J. Pharm. Biomed. Anal. 14: 655–657 (1996).
[8]	International conference on Harmonization, ICH Q3b(R2) 2006.
[9]	International conference on Harmonization, ICH Q2(R1) 2005.
[10]	David M Bliesner. Validating chromatographic methods a practical guide. Wiley Interscience. 2006.
[11]	Y. Kozakevich. R. Lobrutto. HPLC for pharmaceutical scientists. John Wiley and Sons, Inc. 2007.
[12]	Azarova I. N. Application of lithium perchlorate in RP-HPLC of amino compounds. Azarova I. N., Baram G. I. //Sorbtion and chromatographic processes. 2014 T. 14. Issue 1: 65-74.

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Vasyl A. Cherniy, Svitlana N. Gureeva, Victoriya A. Georgiyants. (2017). Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC. Journal of Drug Design and Medicinal Chemistry, 2(6), 65-73. https://doi.org/10.11648/j.jddmc.20160206.12

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ACS Style

Vasyl A. Cherniy; Svitlana N. Gureeva; Victoriya A. Georgiyants. Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC. J. Drug Des. Med. Chem. 2017, 2(6), 65-73. doi: 10.11648/j.jddmc.20160206.12

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AMA Style

Vasyl A. Cherniy, Svitlana N. Gureeva, Victoriya A. Georgiyants. Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC. J Drug Des Med Chem. 2017;2(6):65-73. doi: 10.11648/j.jddmc.20160206.12

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@article{10.11648/j.jddmc.20160206.12,
  author = {Vasyl A. Cherniy and Svitlana N. Gureeva and Victoriya A. Georgiyants},
  title = {Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC},
  journal = {Journal of Drug Design and Medicinal Chemistry},
  volume = {2},
  number = {6},
  pages = {65-73},
  doi = {10.11648/j.jddmc.20160206.12},
  url = {https://doi.org/10.11648/j.jddmc.20160206.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jddmc.20160206.12},
  abstract = {The aim of the present study was to develop and validate HPLC method for determination of related substances of benzydamine hydrochloride in a dosage form, containing benzydamine hydrochloride as an active substance. A new selective, specific and sensitive method was developed for determination of benzydamine degradation products in the formulation. Determination was carried out by reversed-phase HPLC using isocratic solvent elution. The method was validated and found to be precise, accurate and specific; the detector response was linear over 0,05% - 1.2% relative to the nominal concentration of benzydamine hydrochloride in the formulation. The developed HPLC method is useful for determination of benzydamine hydrochloride related substances in formulations and can be applied in Quality Control Laboratories.},
 year = {2017}
}

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TY  - JOUR
T1  - Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC
AU  - Vasyl A. Cherniy
AU  - Svitlana N. Gureeva
AU  - Victoriya A. Georgiyants
Y1  - 2017/01/10
PY  - 2017
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DO  - 10.11648/j.jddmc.20160206.12
T2  - Journal of Drug Design and Medicinal Chemistry
JF  - Journal of Drug Design and Medicinal Chemistry
JO  - Journal of Drug Design and Medicinal Chemistry
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EP  - 73
PB  - Science Publishing Group
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AB  - The aim of the present study was to develop and validate HPLC method for determination of related substances of benzydamine hydrochloride in a dosage form, containing benzydamine hydrochloride as an active substance. A new selective, specific and sensitive method was developed for determination of benzydamine degradation products in the formulation. Determination was carried out by reversed-phase HPLC using isocratic solvent elution. The method was validated and found to be precise, accurate and specific; the detector response was linear over 0,05% - 1.2% relative to the nominal concentration of benzydamine hydrochloride in the formulation. The developed HPLC method is useful for determination of benzydamine hydrochloride related substances in formulations and can be applied in Quality Control Laboratories.
VL  - 2
IS  - 6
ER  -

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Author Information

Vasyl A. Cherniy

JSK “Farmak”, R&D Department, Kiev, Ukraine
Svitlana N. Gureeva

JSK “Farmak”, R&D Department, Kiev, Ukraine
Victoriya A. Georgiyants

Department of Pharmaceutical Chemistry, National Pharmaceutical University, Kharkov, Ukraine

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APA Style

Vasyl A. Cherniy, Svitlana N. Gureeva, Victoriya A. Georgiyants. (2017). Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC. Journal of Drug Design and Medicinal Chemistry, 2(6), 65-73. https://doi.org/10.11648/j.jddmc.20160206.12

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ACS Style

Vasyl A. Cherniy; Svitlana N. Gureeva; Victoriya A. Georgiyants. Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC. J. Drug Des. Med. Chem. 2017, 2(6), 65-73. doi: 10.11648/j.jddmc.20160206.12

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AMA Style

Vasyl A. Cherniy, Svitlana N. Gureeva, Victoriya A. Georgiyants. Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC. J Drug Des Med Chem. 2017;2(6):65-73. doi: 10.11648/j.jddmc.20160206.12

Copy | Download

@article{10.11648/j.jddmc.20160206.12,
  author = {Vasyl A. Cherniy and Svitlana N. Gureeva and Victoriya A. Georgiyants},
  title = {Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC},
  journal = {Journal of Drug Design and Medicinal Chemistry},
  volume = {2},
  number = {6},
  pages = {65-73},
  doi = {10.11648/j.jddmc.20160206.12},
  url = {https://doi.org/10.11648/j.jddmc.20160206.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jddmc.20160206.12},
  abstract = {The aim of the present study was to develop and validate HPLC method for determination of related substances of benzydamine hydrochloride in a dosage form, containing benzydamine hydrochloride as an active substance. A new selective, specific and sensitive method was developed for determination of benzydamine degradation products in the formulation. Determination was carried out by reversed-phase HPLC using isocratic solvent elution. The method was validated and found to be precise, accurate and specific; the detector response was linear over 0,05% - 1.2% relative to the nominal concentration of benzydamine hydrochloride in the formulation. The developed HPLC method is useful for determination of benzydamine hydrochloride related substances in formulations and can be applied in Quality Control Laboratories.},
 year = {2017}
}

Copy | Download

TY  - JOUR
T1  - Development and Validation of Alternative Analytical Method for Determination of Related Substances of Benzydamine Hydrochloride in Oral Spray by HPLC
AU  - Vasyl A. Cherniy
AU  - Svitlana N. Gureeva
AU  - Victoriya A. Georgiyants
Y1  - 2017/01/10
PY  - 2017
N1  - https://doi.org/10.11648/j.jddmc.20160206.12
DO  - 10.11648/j.jddmc.20160206.12
T2  - Journal of Drug Design and Medicinal Chemistry
JF  - Journal of Drug Design and Medicinal Chemistry
JO  - Journal of Drug Design and Medicinal Chemistry
SP  - 65
EP  - 73
PB  - Science Publishing Group
SN  - 2472-3576
UR  - https://doi.org/10.11648/j.jddmc.20160206.12
AB  - The aim of the present study was to develop and validate HPLC method for determination of related substances of benzydamine hydrochloride in a dosage form, containing benzydamine hydrochloride as an active substance. A new selective, specific and sensitive method was developed for determination of benzydamine degradation products in the formulation. Determination was carried out by reversed-phase HPLC using isocratic solvent elution. The method was validated and found to be precise, accurate and specific; the detector response was linear over 0,05% - 1.2% relative to the nominal concentration of benzydamine hydrochloride in the formulation. The developed HPLC method is useful for determination of benzydamine hydrochloride related substances in formulations and can be applied in Quality Control Laboratories.
VL  - 2
IS  - 6
ER  -

Copy | Download