Development and validation of the method quantitative determination of enisamium iodide for the assessment of dissolution profile of antiviral agent
Journal Title: Фармацевтичний журнал - Year 2018, Vol 3, Issue 3
Abstract
Assessment of the dissolution profiles is an important tool for characterization of solid drug products which need to be examined both at the stage of pharmaceutical development, and throughout their life cycle. It is necessary to control the release of the active substance from the dosage form after changes which are related to variation of drug product composition or technology used. The aim of this work was to develop and validate a method for the study of dissolution profiles of the antiviral agent enisamium iodide, tablets. The liquid chromatograph Agilent 1260 (USA) equipped with degasser, four-channel pump, autosampler, chromatographic column thermostat and diode area detector was used. The chromatographic column Zorbax Eclipse XDB-C18, with dimensions 150 × 4.6 mm, filled by octadecylsilane sorbent, with a particles size of 5 μm, was used. The mobile phase is a mixture of a buffer solution of pH 2.5 containing sodium octane-1-sulfonate in an amount of 0.1%, water, acetonitrile (30:35:35 v/v/v). The dissolution tester ERWEKA DT 820 (Germany) was also used. During the validation such parameters as specificity, accuracy, precision and robustness were confirmed. The correlation coefficients of linear regression (r) between the entered and found values for enisamium iodide is greater than 0.995. Stability of the reference solutions and test solutions at storage at room temperature for 24 hours has been confirmed. The developed HPLC method of the quantitative determination of enisamium iodide can be used for study of the dissolution profiles of enisamium iodide tablets.
Authors and Affiliations
O. V. Burmaka
Keywords
Related Articles
- EP ID EP551696
- DOI 10.32352/0367-3057.3-4.18.06
- Views 109
- Downloads 0
Retrospective analysis and current state of the improving qualification of pharmacists on quality questions of medicines in Shupyk NMAPE
To date, one of the advanced educational and research centers of Kiev and Ukraine, which is the improving qualification of pharmacists on quality questions of medicines, is the Department of Quality Control and Standardi...
Development of laboratory technology of the ointment Allergolik
Today quite important and urgent task of modern medicine and pharmacy is expanding the range of herbal medicines for the treatment of dermatitis with secondary fungal skin lesions. The objective of the work is developme...
Analysis of evidence-based information about herbal medicines used for treatment of pregnancy
WHO adopted the "Strategy traditional medicine: 2014-2013", that provides the development of databases (knowledge base) of traditional herbal medicines for use in national Drug policy. The goal of this article was to...
Modern tendency of creating cosmetic preparations for the dry skin with the use ofapiculture products
The skin xerosis problem in cosmetology becomes more and more topical, as it grows each year which is caused by the environmental conditions and frequency of dermatological diseases. The objective of the paper is to cre...
Assessment and ranking of scientific-pedagogical staff of the university as a component of the quality assurance system of higher pharmaceutical education
Integration of higher pharmaceutical education in the world educational and scientific space activates the formation of a proper system of quality assurance of educational services to future professionals in the pharmace...