Abstract
To determine the physicochemical and microbiological stability of sulfadiazine suspensions (100mg/mL) in simple syrup (A) and sorbitol (B) formulations prepared from commercially available tablets. An ultra-performance liquid chromatographic assay was developed and validated to determine the chemical stability of sulfadiazine. Three samples were prepared and stored at 5 and 25°C and assayed at 0, 7, 14 and 30days. Physical parameters (appearance, pH, particle size and viscosity) were also monitored. Microbiological examination was performed through the suitable counting method. The formulations presented a sulfadiazine concentration of around 95% at the beginning at both temperatures. There was some variation in pH, viscosity and particle size distribution over time. The samples met the pharmacopoeia criteria of microbiological quality over 30days, but only sulfadiazine formulated in syrup stored at 25°C was suitable for use after one week. The sulfadiazine suspension in simple syrup was chosen as the most suitable formulation because it demonstrated stability for 14days at room temperature, providing an alternative liquid dosage form of sulfadiazine for congenital toxoplasmosis treatment.
Published Version
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