Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate

, Objectives. Spectrophotometric method is one of the most convenient methods in pharmaceutical analysis, as it is sensitive, precise and cost effective. Therefore, the aim of the present work was the development of simple and available method for the quantitative determination of betahistine dihydr...

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Main Authors: A.O. Donchenko, S. O. Vasyuk
Format: Article
Language:English
Published: Zaporizhzhia State Medical and Pharmaceutical University 2018-04-01
Series:Zaporožskij Medicinskij Žurnal
Subjects:
Online Access:http://zmj.zsmu.edu.ua/article/view/125283/124598
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author A.O. Donchenko
S. O. Vasyuk
author_facet A.O. Donchenko
S. O. Vasyuk
author_sort A.O. Donchenko
collection DOAJ
description , Objectives. Spectrophotometric method is one of the most convenient methods in pharmaceutical analysis, as it is sensitive, precise and cost effective. Therefore, the aim of the present work was the development of simple and available method for the quantitative determination of betahistine dihydrochloride in dosage forms. Materials and methods. Sodium 1,2-napthoquinone-4-sulphonate was assessed as chemical reagent for the quantitative determination of betahistine dihydrochloride by visible spectrophotometric method. Results. Different variables affecting the reactions between sodium 1,2-napthoquinone-4-sulphonate and the drug were carefully studied and optimized. It was established that betahistine dihydrochloride reacts with sodium 1,2-napthoquinone-4-sulphonate in alkaline medium with the colored reaction product formation with absorption maximum at 485 nm. The proposed method was subjected to validation tests. The method was validated for the parameters like linearity, precision, accuracy, robustness and scope of application. Beer’s law was obeyed over the concentration range of 2.40–4.00 mg/100 ml. Parameters of linear dependence were calculated with the help of regression analysis by means of least squares. Coefficients of stoichiometric relationship were also determined by means of molar ratios and continuous changes. The proposed procedure meets the requirements of State Pharmacopoeia of Ukraine that are made for dosage forms. Conclusion. On the basis of the carried out investigations of betahistine dihydrochloride quantitative determination, spectrophotometric procedure has been developed and validated. This procedure is successfully applied for dosage forms analysis. Investigation results show that the procedure is highly sensitive, precise, simple in performance and relevant to be applied at the quality control laboratories for dosage forms.
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spelling doaj-art-dcdb281dca9740918b6f2c3f5c013bfe2025-08-20T03:26:15ZengZaporizhzhia State Medical and Pharmaceutical UniversityZaporožskij Medicinskij Žurnal2306-41452310-12102018-04-01224825210.14739/2310-1210.2018.02.125283Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonateA.O. DonchenkoS. O. Vasyuk, Objectives. Spectrophotometric method is one of the most convenient methods in pharmaceutical analysis, as it is sensitive, precise and cost effective. Therefore, the aim of the present work was the development of simple and available method for the quantitative determination of betahistine dihydrochloride in dosage forms. Materials and methods. Sodium 1,2-napthoquinone-4-sulphonate was assessed as chemical reagent for the quantitative determination of betahistine dihydrochloride by visible spectrophotometric method. Results. Different variables affecting the reactions between sodium 1,2-napthoquinone-4-sulphonate and the drug were carefully studied and optimized. It was established that betahistine dihydrochloride reacts with sodium 1,2-napthoquinone-4-sulphonate in alkaline medium with the colored reaction product formation with absorption maximum at 485 nm. The proposed method was subjected to validation tests. The method was validated for the parameters like linearity, precision, accuracy, robustness and scope of application. Beer’s law was obeyed over the concentration range of 2.40–4.00 mg/100 ml. Parameters of linear dependence were calculated with the help of regression analysis by means of least squares. Coefficients of stoichiometric relationship were also determined by means of molar ratios and continuous changes. The proposed procedure meets the requirements of State Pharmacopoeia of Ukraine that are made for dosage forms. Conclusion. On the basis of the carried out investigations of betahistine dihydrochloride quantitative determination, spectrophotometric procedure has been developed and validated. This procedure is successfully applied for dosage forms analysis. Investigation results show that the procedure is highly sensitive, precise, simple in performance and relevant to be applied at the quality control laboratories for dosage forms.http://zmj.zsmu.edu.ua/article/view/125283/124598betahistine dihydrochloridesodium 12-napthoquinone-4-sulphonatespectrophotometryvalidation studies
spellingShingle A.O. Donchenko
S. O. Vasyuk
Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate
Zaporožskij Medicinskij Žurnal
betahistine dihydrochloride
sodium 1
2-napthoquinone-4-sulphonate
spectrophotometry
validation studies
title Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate
title_full Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate
title_fullStr Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate
title_full_unstemmed Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate
title_short Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate
title_sort betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1 2 napthoquinone 4 sulphonate
topic betahistine dihydrochloride
sodium 1
2-napthoquinone-4-sulphonate
spectrophotometry
validation studies
url http://zmj.zsmu.edu.ua/article/view/125283/124598
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AT sovasyuk betahistinedihydrochloridequantitativedeterminationindosageformsbythereactionwithsodium12napthoquinone4sulphonate