DOI: https://doi.org/10.22263/2312-4156.2020.2.89
Adamenko G.V., Martsinkevich A.F.
Validation of quantitative determination methods of brilliant green and сrystalline iodine in alcohol-containing antiseptic medicinal agents
Vitebsk State Order of Peoples’ Friendship Medical University, Vitebsk, Republic of Belarus
Vestnik VGMU. 2020;19(2):89-95.
Abstract.
The validation of the analytical methodology is carried out with the aim to prove experimentally the suitability of the methods for solving the proposed problem. Quantitative determination methods, including impurity determination ones and those used for determining the content limit are subject to validation. When validating the methods for quantitative determination of active pharmaceutical substances and other components of drugs, the same validation characteristics are used. During validation, the analytical methodology is evaluated according to the following characteristics: specificity, detection limit, limit of quantification, analytical domain, linearity, correctness, precision, stability. The characteristics choice depends on the technique type.
The aim of the study was the adaptation and validation of quantitative determination methods of brilliant green in the antiseptic drugs «Vitasept-SKZ» and «Vitasept-SKZ-A» and crystalline iodine in «Vitasept-SKI».
Drugs based on ethyl alcohol with brilliant green («Vitasept-SKZ», «Vitasept-SKZ-A»), crystalline iodine («Vitasept-SKI») used for prophylactic antisepsis served as an object of research.
The subject of the study was the methods for quantitative determination of brilliant green («Vitasept-SKZ», «Vitasept-SKZ-A») and crystalline iodine («Vitasept-SKI») in drugs by means of titration.
Validation was carried out in accordance with TKP 432-2012 (02041) «Production of medicines. Validation of test methods» and TKP 438-2012 (02041) «Production of medicines. Application of statistical validation methods».
The techniques for quantitative determination of brilliant green in «Vitasept-SKZ» and «Vitasept-SKZ-A» and crystalline iodine in «Vitasept-SKI» antiseptic medicinal agents with the help of titration method according to the indices of specificity, linearity, convergence, intralaboratory precision, correctness and range of defined contents have been adapted and validated.
Key words: validation, titration, iodometry, Vitasept-SKZ, Vitasept-SKI, Vitasept-SKZ-A, brilliant green, crystalline iodine.
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Information about authors:
Adamenko G.V. – senior lecturer of the Chair of Organization & Economy of Pharmacy with the course of the Faculty for Advanced Training & Retraining, Vitebsk State Order of Peoples’ Friendship Medical University;
Martsinkevich A.F. – Candidate of Biological Sciences, senior lecturer of the Chair of General & Clinical Biochemistry with the course of the Faculty for Advanced Training & Retraining, Vitebsk State Order of Peoples’ Friendship Medical University.
Correspondence address: Republic of Belarus, 210009, Vitebsk, 27 Frunze ave., Vitebsk State Order of Peoples’ Friendship Medical University, Chair of Organization & Economy of Pharmacy with the course of the Faculty for Advanced Training & Retraining. E-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Gennadiy V. Adamenko.
