Нажмите на эту строку чтобы перейти к Новостям сайта "Русский врач"

Перейти
на сайт
журнала
"Врач"
Перейти на сайт журнала "Медицинская сестра"
Перейти на сайт журнала "Фармация"
Перейти на сайт журнала "Молекулярная медицина"
Перейти на сайт журнала "Вопросы биологической, медицинской и фармацевтической химии"
Журнал включен в российские и международные библиотечные и реферативные базы данных

ВАК (Россия)
РИНЦ (Россия)
Эко-Вектор (Россия)

IDENTIFICATION AND QUANTITATION OF FEXOFENADINE HYDROCHLORIDE IN MODEL ORAL DROPS

DOI: https://doi.org/10.29296/25877313-2023-07-06
Issue: 
7
Year: 
2023

Abdulhadi Ashour Bakri
Post-graduate Student, Department of Pharmaceutical Technology, Faculty of Pharmacy,
Belgorod National Research University (Belgorod, Russia).
E.T. Zhilyakova,
Dr.Sc. (Pharm.), Professor, Department of Pharmaceutical Technology, Faculty of Pharmacy,
Belgorod National Research University (Belgorod, Russia),
E-mail: EZhilyakova@bsu.edu.ru
Ghadeer Balloul
Master, Department Pharmaceutical and Chemical Technology,
Belgorod National Research University (Belgorod, Russia)
E-mail: ghadeerballoul@gmail.com
Abdullah Yahya Yousif
Post-graduate Student, Department of Pharmaceutical Technology, Faculty of Pharmacy,
Belgorod National Research University (Belgorod, Russia)
A.V. Taran
Ph.D (Pharm.), Senior Lecturer, Department of Pharmaceutical Technology,
Belgorod National Research University (Belgorod, Russia)

Relevance. Fexofenadine hydrochloride is a representative of the III generation of histamine H1 receptor blockers, therefore, it is not characterized by the disadvantages of antihistamines, such as: suppression of the central nervous system, cardiotoxic effect, headache, impaired coordination of movements, photosensitivity. Analysis of fexofenadine hydrochloride was performed using UV spectroscopy. The purpose of the study – development of a new analytical method for the qualitative and quantitative identification of fixofenadine in drops for in-ternal use. Material and methods. The study used: fexofenadine, sodium hydroxide, water for injection, UV spectrophotometer type SF-104. Results and conclusions. A method for the qualitative and quantitative determination of fexofenadine hydrochloride in model drops for internal use by the SPS method has been proposed. This method meets the requirements of OFS 1.1.0012.15 Validation of analytical methods, in terms of indica-tors: linearity and analytical area, correctness, precision.

Keywords: 
fexofenadine hydrochloride
spectrophotometer
optical density
oral drops
liquid dosage forms.

References: 
  1. Fouad M., Ragab M. Effectiveness and safety of fexofenadine in chronic idiopathic urticaria − open-label noncomparative study in daily practice. The Egyptian Journal of Dermatology and Venerolo-gy. 2017; 2(37): 43–48.
  2. Horn M.M., Nguyen A.L., Bielory L. Allergic conjunctivitis and dry eye syndrome. Ann Allergy Asthma Immunol. – 2012. 108 (3): P. 163-166.
  3. Van Cauwenberge P., Juniper E.F. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy. 2000 Jun; 30(6): 891–899. DOI: 10.1046/j.1365-2222.2000.00914.x.
  4. Howarth P.H., Stern M.A., Roi L., Reynolds R., Bousquet J. Dou-ble-blind, placebocontrolled study comparing the efficacy and safety of fexofenadine hydrochloride (120 and 180 mg once daily) and ce-tirizine in seasonal allergic rhinitis. J Allergy Clin Immunol. 1999 Nov; 104(5): 927–933. DOI: 10.1016/s0091-6749(99)70070-9. PMID: 10550734.
  5. Gross G.N., Ganster K., Meeves S., Liao Y., Georges G.C. A dou-ble-blind, randomized comparison of fexofenadine 180 mg versus cetirizine 10 mg: effect on instantaneous symptom score at the 24th hour. Ann Allergy Asthma Immunol. 2003; 90: 125.
  6. Hampel F., Ratner P., Mansfield L., Meeves S., Liao Y., Georges G. Fexofenadine hydrochloride, 180 mg, exhibits equivalent effica-cy to cetirizine, 10 mg, with less drowsiness in patients with mod-erate-to-severe seasonal allergic rhinitis. Ann Allergy Asthma Im-munol 2003; 91: 354–361.
  7. Sareen S., Mathew G., Joseph L. Improvement in solubility of poor water-soluble drugs by solid dispersion. Int. J. Pharm. Investig. 2012; 2(1): 12–17.
  8. Schoenwald R.D. Ocular pharmacokinetics. Textbook of Ocular Pharmacology; Lippincott-Raven: Philadelphia, PA, USA. 1997: 119–138.
  9. CH Topic Q 2 (R1) Validation of Analytical Procedures. Text and Methodology: June 1995, CPMP/ICH/381/95 / European Medi-cines Agency. London. 2006. 15 p. [Electronic resource]. Mode of access: http://www.ema.europa.eu/docs/en_ GB/document_library/Scientific_guideline/2009/09/WC5000 02662.pdf.
  10. Gosudarstvennoj farmakopei Rossijskoj Federacii, OFS.1.1.0012.15 Validaciya analiticheskih metodik [In Russia] (Государственной фармакопеи Российской Федера-ции, ОФС.1.1.0012.15 Валидация аналитических методик).
  11. Uing G. Instrumental'nye metody analiza. Moskva: Mir, 1989. 608 s. [In Russia] (Юинг Г. Инструментальные методы анализа. Москва: Мир, 1989. 608 с.)
  12. Yakusheva E.N., Chernyh I.V., Shchul'kin A.V., Gacanoga M.V. Razrabotka VEZHKH-metodiki kolichestvennogo analiza feksofenadina v plazme krovi. Farmakokinetika i farmakodinamika. 2017; 2: 35–38. [In Russia] (Якушева Е.Н., Черных И.В., Щулькин А.В., Гацанога М.В. Разра-ботка ВЭЖХ-методики количественного анализа фексо-фенадина в плазме крови. Фармакокинетика и фармакодинамика. 2017; 2: 35–38.)
  13. Krishnan S.K., Veerasamy R., Thiyagu R., Dharamsi A., Raja M. Spectrophotometric Determination of Fexofenadine hydrochloride. Indian Journal of Pharmaceutical Sciences. 2006; 68(6): 841–842.
  14. Rajan V. UV Spectrophotometric Estimation of Fexofenadine hy-drochloride by First Order Derivative and Area under Curve Meth-ods in Bulk and Pharmaceutical Dosage Form. Der Pharmacia Let-tre. 2016; 8(10): 95–101.
  15. British Pharmacopoeia 2009; Volume I and II; 2494–2500. 15. XIV.