Long-term stability of the hydrochlorides of tramadol and alizapride in dextrose 5% polyolefin bag at 5±3°C
(2010) Annales Pharmaceutiques Francaises — Vol. 68, n° 3, p. 157-162 (2010)
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- Objective: To investigate the stability of tramadol hydrochloride 100. mg associated with alizapride 50. mg in 100. ml of 5% dextrose solution stored at 5 ± 3°C. Methods: Solutions of 5% dextrose 100. ml in polyolefin bags (n=5) containing approximately tramadol hydrochloride 100. mg associated with alizapride 50. mg were prepared under aseptic conditions and stored about 32 days at 5 ± 3°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). Results: No color change or precipitation in the solutions was observed. Tramadol hydrochloride 100. mg associated with alizapride 50. mg in 100. ml of 5% dextrose infusions was stable when stored at 5 ± 3°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.
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Athanasoupoulos, A., Hecq, J.-D., Vanbeckbergen, D., Jamart, J., & Galanti, L. (2010). Long-term stability of the hydrochlorides of tramadol and alizapride in dextrose 5% polyolefin bag at 5±3°C. Annales Pharmaceutiques Francaises, 68(3), 157-162. https://doi.org/10.1016/j.pharma.2010.03.004 (Original work published 2010)