Резюме

Куликов А.Ю., Байва П.П., Баранова І.І. Ідентифікація та кількісне визначення фузідієвої кислоти у гелі для лікування вугрової хвороби І-ІІ стадії.

Розробили методики високоефективної рідинної хроматографії (ВЭЖХ) для визначення фузі дієвої кислоти в новому лікарському засобі, а також її валідацію для цілей кількісного визначення за вимогами ДФУ. Встановлено, що запропоновані сучасні методики відповідали вимогам ДФУ, забезпечують специфічність, точність та відтворюваність результатів, дозволяють одночасно проводити кількісне визначення та ідентифікацію досліджуваних речовин у розробленому гелі.

Ключові слова: вугрова хвороба, гель, фузідієва кислота, високоефективна рідинна хроматографія.

Резюме

Куликов А.Ю., Байва П.П., Баранова И.И. Идентификация и количественное определение фузидиевои кислоты в геле для лечения угревой болезни I-II стадии.

Разработали методики высокоэффективной жидкостной хроматографии (ВЭЖХ) для определения ФК в новом лекарственном средстве, а также ее валидацию для целей количественного определения по требованиям Государственной фармакопеи Украины. Установлено, что предложенные современные методики соответствовали требованиям ГФУ, обеспечивают специфичность, точность и воспроизводимость результатов, позволяющих одновременно проводить количественное определение и идентификацию исследуемых веществ в геле.

Ключевые слова: угревая болезнь, гель, фузидиевая кислот, высокоэффективная жидкая хроматография.

Summary

Kulikov A.Y., Bayva P.P., Baranova I.I. Identificaton and quantification of fuzid acid gel acne treatment stage I-II.

A method of high performance liquid chromatography (HPLC ) to determine the FC in the new medicines, as well as its validation for the quantitative determination of the requirements for the ДФУ (Pharmacopoeia of Ukraine) . Found that the proposed methodology meet the requirements of modern HFC provide specificity, accuracy and reproducibility of results, enabling both a quantitative detection and identification of analytes in the gel.

Key words: acne, gel, fuzid acid, high performance liquid chromatography.

Рецензент: д.фарм.н., проф. Л.Г. Алмакаєва

UDK 615.262: 615.454.12:615.07

IDENTIFICATION AND QUANTITATIVE DETERMINATION OF FUSIDIC ACID IN THE GEL FOR THE TREATMENT OF THE ACNE VULGARIS OF  I-II STAGE

Kulikov A.Y., Baiva P.P., Baranova I.I.

THE NATIONAL UNIVERSITY OF PHARMACY

aromafarm@mail.ru

Acne vulgaris is a very common skin disease. Statistically, 80 % of the population aged 12 to 25 years, and about 30-40 % of people over 25 years suffer from this disease. The trend of "growing up" of this disease nowadays, its significant influence on the psycho-emotional sphere, social status and social adaptation of patients determine the actuality of this problem and the need to develop the new effective drugs.

At the base of National University of Pharmacy (Kharkiv, Ukraine) it was made the gel for the treatment of Acne vulgaris of I-II stage. In the gel as a biologically active substance it was added the fusidic acid. It has an antimicrobial action.

The aim of this study was to develop a method of high efficiency liquid chromatography for determination of the FA in the new drugs, as well as its validation for the purpose of quantitative determination according to the requirements of Pharmacopoeia of Ukraine (ДФУ).

Tests on the identification of selected FA were carried out in accordance with the requirements of SPU 2.2.29. In the chromatogram of the sample solution the retention time of  fusidic acid peaks correspond to the retention time of fusidic acid peaks in the chromatogram of blank.

 Under specific conditions, the peak of fusidic acid is separated from the auxiliary components of the gel.

The comparative standard deviation of the fusidic acid peak areas must correspond to the requirements of 2.2.46 (SPU 1.2).

The specificity of the methods is confirmed by the placebo of chromatograms and fusidic acid. It was shown that in the chromatogram of the solution placebo there are no peaks with retention time, which coincides with the retention time of fusidic acid.

In the developed conditions it was examined the dependence of detector reaction from the concentration of fusidic acid. For the receiving of information about linear dependence it were prepared the solutions of  fusidic acid, containing in its composition   80 %, 90 %, 100 %, 110% and 120 % from the nominal composition.

According to the received information it was made the diagram.

To determine the accuracy of the method it was chromatographed the standard sample solution of fusidic acid and with the obtained information it were calculated the percentage of the found fusidic acid.

It was used the method of standard components to check the slowness of methodology.

It was also checked the reproducibility of methods. The received data show that the method is consistent and reproduces on different days.

Based on the calculated data of fusidic acid in formulation was developed HPLC method for quantitative determination of fusidic acid in the gel for the treatment of the Acne vulgaris of I-II stage.

The specificity of the method is confirmed by the chromatogram placebo by comparative solution and a typical chromatogram of the test solution of active substance which are determined. The additional component of drugs has not influence at determining of fusidic acid.

 Research of on validation techniques HPLC of quantitative determination of fusidic acid in the topic gel.

The proposed methodology correspond to the requirements of Pharmacopoeia of Ukraine (ДФУ), ensure the specificity, accuracy and reproducibility of results, allowed to make the quantification determination and identification of these substances in the gel.