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.
Subject(s)
Bacteria/isolation & purification , Bromides/chemistry , Drug Contamination , Fungi/isolation & purification , Pharmaceutical Solutions/chemistry , Plant Extracts/chemistry , Plant Preparations/chemistry , Sodium Compounds/chemistry , Administration, Oral , Chromatography, High Pressure Liquid , Drug Compounding , Drug Stability , Humans , Leonurus , ValerianABSTRACT
The physical and chemical stability of a stock preparation ointment with active ingredients-herbal tinctures of calendula and arnica-for the treatment of hemorrhoids was studied. Evaluations for physical and chemical stability were performed initially and throughout the storage period. Physical stability of the ointment was assessed by means of visual observation in normal room light. Throughout the study period, the physical appearance of the ointment did not change. The chemical stability of the ointment was evaluated by means of a stability-indicating, thin-layer chromatography analytical technique. The shelf-life was found to be one month at 25 degrees C +/- 2 degrees C/60% RH and two months at 5 degrees C +/- 3 degrees C, when protected from light.
