Long-term stability of the hydrochlorides of tramadol and alizapride in dextrose 5% polyolefin bag at 5 ± 3 °C

Abstract

To investigate the stability of tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose solution stored at 5+/-3 degrees C. Solutions of 5% dextrose 100ml in polyolefin bags (n=5) containing approximately tramadol hydrochloride 100mg associated with alizapride 50mg were prepared under aseptic conditions and stored about 32 days at 5+/-3 degrees C. The tramadol hydrochloride and alizapride concentrations were measured by high-performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage. Stability of the solutions was defined as the common regression line 95% lower confidence limit of the concentration remaining superior to 90% of the initial concentration as recommended by the Food and Drug Administration (FDA). No color change or precipitation in the solutions was observed. Tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose infusions was stable when stored at 5+/-3 degrees C during 32 days. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. There was no significant change in pH during storage. Under the conditions of this study, tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose infusions stored up to 32 days at 5+/-3 degrees C remain stable and may be prepared in advance by a Centralized Intravenous Additive Service (CIVAS) to improve safety and management.