Investigation of the Physical, Chemical, and Microbiological Stability of Oral Solutions Compounded with Herbals

Khokhlova, K.O.; Zdoryk, O.A.

International Journal of Pharmaceutical Compounding 22(3): 240-246

2018


ISSN/ISBN: 1092-4221
PMID: 29878891
Accession: 065257120

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Abstract
The physical, chemical, and microbiological stability of a compounded oral solution with the active ingredients herbal tinctures of valerian and motherwort with sedative action for pediatric treatment was studied. Evaluations for physical, chemical, and microbiological stability were performed initially and throughout the storage period. Physical stability of the oral solution was assessed by coloration, clarity, and pH of the solution. The physical appearance of the oral solution did not change throughout the study period. The chemical stability of the oral solution was evaluated by means of a stability-indicating high-performance thin-layer chromatography analytical technique, identification tests, and assay method of sodium bromide. The microbiological stability of the oral solution was investigated by using the European Pharmacopoeia method using the acceptance criteria for nonsterile aqueous preparations for oral use. It was found that the compounded oral solution was stable for at least 21 days at 25°C ± 2°C/60% RH and 5°C ± 3°C, when protected from light.