Development of the method for quantitative determination of phenylephrine hydrochloride in the combined drops
DOI:
https://doi.org/10.24959/nphj.14.1990Keywords:
phenylephrine hydrochloride, validation, quantitative determination, spectrophotometry, combined nasal dropsAbstract
The work is devoted to development of the method for quantitative determination of phenylephrine hydrochloride in the combined nasal drops Gripocitron Rinis. Combination of phenylephrine hydrochloride possessing the vasoconstrictor action with dimetindene maleate having the antihistaminic action formulated into drops decreases nasal discharge and helps to clear the nasal passages without disturbing physiological functions of the ciliated epithelium and mucous membrane. It has been found that the quantitative content of phenylephrine hydrochloride in the combined nasal drops can be determined by spectrophotometry in the ultraviolet spectrum at the wavelength of 296 nm. The method proposed demonstrates the possibility of phenylephrine hydrochloride determination in combined drops in the presence of another active pharmaceutical ingredient – dimetindene maleate, which has the absorption minimum in sodium hydroxide solution at this wavelength. The influence of the additional ingredient – benzalkonium chloride drops on the nature of the absorption spectrum of phenylephrine hydrochloride is recommended to eliminate by the action of potassium dichromate solution. The optimal amount and concentration of solutions of sodium hydroxide and potassium dichromate, the analytical band have been determined. Validation of the given method has been carried out according to the following validation characteristics: linearity (a = 4.34 ≤ maxa 5.10%, b = 1.04), accuracy (0.52 ≤ maxδ 1.02%), convergence (1.07% ≤ max Δas 3.20%) and the correlation coefficient r, which is 0.9997. It has been found that the method suggested for determination of phenylephrine hydrochloride in nasal drops is precise, accurate, reproducible and linear, and it allows recommending it for using in pharmaceutical analysis.
References
Бевз Н.Ю., Криванич О.В., Георгіянц В.А. // Фармацевтичний часопис. – 2013. – №2. – C. 57-61.
Гризодуб А.И. Стандартизованные процедуры валидации методик контроля качества лекарственных средств // В кн.: «Аналитическое обеспечение создания, стандартизации и контроля качества лекарственных средств» / Под ред. В.П.Георгиевского. – Х.: ООО «НТМТ». – Т. 1. – 2011. – С. 934-1063.
Державна фармакопея України / Державне підприємство «Науково-експертний фармакопейний центр». – 1-е вид. – Доп. 2. – Х.: Державне підприємство «Науково-експертний фармакопейний центр», 2008. – 620 с.
Машковский М.Д. Лекарственные средства. – 16-е изд., перераб., испр. и доп. – М.: Новая волна, 2012. – 1216 с.
British Pharmacopoeia, 13th Version and Suppl. – 1 Electron. Optic. Disc (CD-ROM) (2009).
Erk N. // J. Pharm. Biomed. Anal. – 2000. – Vol. 23. – P. 1023.
Marı́n A., Barbas C. // J. Pharm. and Biomed. Analysis. – 2004. – Vol. 35, №4. – Р. 769-777.
Othman N.S., Fatah N.T.A. // Tikrit J. of Pure Sci. – 2011. – Vol. 16, №2. – Р. 67-74.
Savic I., Bankovic V., Nikolic G. // Maced. J. Chem. Eng. – 2008. – Vol. 27, №2. – Р. 149-156.
United States Pharmacopeia / National Formulary (USP31-NF26) / The United States Pharmacopeial Convention, Inc. : Rockville, MD. – 2008. – Vol. 2. – P. 2987.
Downloads
Published
Issue
Section
License
Copyright (c) 2014 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).