IDENTIFICATION OF ACTIVE INGREDIENTS AND RELATED IMPURITIES IN A COMBINED DRUG PREPARATION USING THIN LAYER CHROMATOGRAPHY METHOD

2025

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DOI 10.53511/pharmkaz.2025.39.77.030
Data confidence 70 medium
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Abstract

The pharmaceutical analysis of combined drugs is associated with certain difficulties associated with the simultaneous detection of active ingredients and their related impurities in one drug. This paper presents the first developed method for the identification of active ingredients and possible concomitant impurities in the combined antiviral drug “Glitsavir” using thin-layer chromatography. Optimal conditions for chromatographic analysis were selected and the validation characteristics of the method — specificity, robustness and precision — were studied. Validation characteristics were studied on 5 series of laboratory samples of effervescent tablets. In the model mixture, the identity of glycyrrhizic acid, ascorbic acid and acyclovir, as well as a related impurity of acyclovir — (2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl) methoxy] ethyl acetate) was confirmed.