ABSTRACT
The purpose of this study was to extemporaneously formulate a liquid dosage form from commercially available tablets and establish the chemical stability of the drug. A suspension of spironolactone (5mg/mL) was formulated from 25-mg spironolactone tablets. Stability-indicating, high perfpromance liquid chromatography assay procedures were used to analyze the concentration of the drug. Chemical stability was predicted using accelerated stability studies. The stability studies were conducted at four temperatures, namely 5*, 30*, and 50*, and 60*C. The spironolactone suspension showed less than 10% degradation at all four temperatures for a period of three months. It appears that the formulation may be stable for longer periods of time; however, the investigation did not extend past this timeline and no recommendation should be implied.
ABSTRACT
The purpose of this study was to extemporaneously formulate a liquid dosage form from commercially available tablets and establish the chemical stability of the drug. A suspension of metronidazole (15 mg/mL) was formulated from 500-mg metronidazole tablets. Stability-indicating, high-performance liquid chromatography assay procedures were utilized to analyze the concentration of the drug. Chemical stability was predicted using accelerated stability studies conducted at four temperatures, namely, 40 deg, 50 deg, 60 deg, and 70 deg C for metronidazole. The Arrhenius plot was used to predict the shelf-life of the metronidazole suspension at room temperature. The shelf-life was calculated from the initial concentration and k0 was found to be 73 years. Howwever, it would be more reasonable to expect that a quantity lasting no more than 90 days should be prepared and dispensed.
