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

Authors

  • A.O. Donchenko Zaporizhzhia State Medical University, Ukraine,
  • S. O. Vasyuk Zaporizhzhia State Medical University, Ukraine,

DOI:

https://doi.org/10.14739/2310-1210.2018.02.125283

Keywords:

betahistine dihydrochloride, sodium 1, 2-napthoquinone-4-sulphonate, spectrophotometry, validation studies

Abstract

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.

References

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How to Cite

1.
Donchenko A, Vasyuk SO. Betahistine dihydrochloride quantitative determination in dosage forms by the reaction with sodium 1,2-napthoquinone-4-sulphonate. Zaporozhye Medical Journal [Internet]. 2018Mar.7 [cited 2024Nov.23];(2). Available from: http://zmj.zsmu.edu.ua/article/view/125283

Issue

No. 2 (2018)

Section

Problems of pharmacy

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