Abstract

Actuality. Nowadays, the problems of effectiveness and accessibility of dermatoprotective therapy and prevention of dermatological diseases are urgent. The complex use of metronidazole in combination with drugs of other pharmacological groups is particularly relevant and promising. The dosage form consisting of 0.1 g of Itraconazole, 0.1 g of metronidazole and Tizol gel up to 10 g, termed by us Metroitraconazole, can be used in dermatology, ophthalmology and gynecology as a bactericidal and antifungal agent.
 The aim of the study is to develop the method for the quantitative spectrophotometric determination of metronidazole and itraconazole in a soft dosage form on a titanium-containing base. Materials and methods. For the analysis, we used substances, ethanol solutions of Metronidazole and Itraconazole, an ointment with the conditional name Metroitraconazole, containing 1.0% of the preparations in the Tizol gel. The study was carried out by spectrophotometry in the ultraviolet region, using spectrophotometer SF-2000 (Russia).
 Results. The study of the absorption spectra and statistical processing of the finding demontstrated that spectrophotometric determination of Itraconazole and metronidazole demanded the wavelengths of 262 and 312 nm, with a relative error of 1.52% and 1.67%, respectively. As a result of the analysis of the soft dosage form, it was determined that the content of metronidazole calculated with the use of Firordt method and a simplified system of equations ranged 0.0987-0.1057 g, and Itraconazole ranged 0.0925-0.1055 g. These data conformed the acceptance criteria.
 Conclusion. The conducted research allowed us to develop and propose a method for the quantitative determination of itraconazole and metronidazole in Metroitraconazole ointment by means of spectrophotometric method. It allowed us to determine the content of drugs in the dosage form with an error not exceeding the standard deviations.

Highlights

  • The aim of the study is to develop the method for the quantitative spectrophotometric determination of metronidazole and itraconazole in a soft dosage form on a titanium-containing base

  • The study of the absorption spectra and statistical processing of the finding demontstrated that spectrophotometric determination of Itraconazole and metronidazole demanded the wavelengths of 262 and 312 nm, with a relative error of ±1.52% and ±1.67%, respectively

  • As a result of the analysis of the soft dosage form, it was determined that the content of metronidazole calculated with the use of Firordt method and a simplified system of equations ranged 0.0987-0.1057 g, and Itraconazole ranged 0.0925-0.1055 g

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Summary

Introduction

Лекарственная форма, состоящая из 0,1 г итраконазола, 0,1 г метронидазола и геля «Тизоль» до 10 г, названная нами «Метроитраконазоль», может найти применение в дерматологии, офтальмологии и гинекологии, как бактерицидное и противогрибковое средство. Цель исследования — разработка способа количественного спектрофотометрического определения метронидазола и итраконазола в мягкой лекарственной форме на титансодержащей основе. Для проведения анализа использовали субстанции, этанольные растворы метронидазола и итраконазола, мазь под условным наименованием «Метроитраконазоль», содержащую по 1,0 % препаратов в геле «Тизоль». В результате анализа мягкой лекарственной формы определено, что содержание метронидазола, рассчитанное по методу Фирордта и упрощенной системе уравнений, находится в пределе 0,0987–0,1057 г, итраконазола — 0,0925–0,1055 г, что соответствует допустимым нормам. Проведенные исследования позволили разработать и предложить способ количественного определения итраконазола и метронидазола в мази «Метроитраконазоль» спектрофотометрическим методом, позволяющий устанавливать содержание препаратов в лекарственной форме с ошибкой, не превышающей нормативные отклонения

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