Analytical Support For The Pharmaceutical Development Of An Original Combined Hepatoprotective Drug In Tablet Form
DOI:
https://doi.org/10.60988/p.v38i3.170Keywords:
hepatoprotective drug, liquid chromatography, pharmaceutical development, selenomethionine, silymarin, tablets, thioctic acid, UV spectrophotometry, validation.Abstract
Analytical support for the pharmaceutical development of key quality indicators of an original combined drug containing thioctic acid, silymarin, and selenomethionine, in accordance with the requirements of the State Pharmacopoeia of Ukraine (harmonized with the European Pharmacopoeia, Eur.Ph.) for oral dosage forms, specifically tablets, was carried out. The methods for the identification and quantitative determination of thioctic acid in the finished dosage form using liquid chromatography were developed, standardized, and validated. Similarly, methods for the identification and quantitative determination of silymarin using UV spectrophotometry were developed, standardized, and validated. Validation studies for the developed quantitative methods for thioctic acid and silymarin demonstrated that the validation characteristics, such as the predicted total uncertainty of the analysis, specificity, linearity, precision (repeatability), and accuracy, were found to meet the established acceptance criteria. A method for the identification of selenomethionine using a color reaction and a method for its quantitative determination using inductively coupled plasma atomic emission spectrometry (ICP-AES) were developed. Finally, the method for the dissolution test of combined tablets containing silymarin using UV spectrophotometry was developed and its suitability was demonstrated.
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