Long-term stability of tramadol chlorhydrate and metoclopramide hydrochloride in dextrose 5% polyolefin bag at 4°C

摘要

Objectives. Preparation of intravenous solution in advance could be efficient to improve quality assurance, security, time management, and cost saving of drug delivery. The purpose of this study was to investigate the stability of a mixture of tramadol chlorhydrate and metoclopramide hydrochloride in dextrose 5% polyolefin bags at 4°C. Methods. The stability of five bags of solution containing 100 mg tramadol and 10 mg metoclopramide per 100 mL dextrose 5% and stored at 4°C was studied during 32 days and concentrations measured by high performance liquid chromatography-diode array detection. Results. No degradation interference nor modification in retention times were observed throughout the study period. At day 32, tramadol concentration was 96.9% ± 2.1 and metoclopramide 97.2% ± 1.3 of the initial concentration. Conclusion. Based on a shelf-life of 90% residual potency, tramadol and metoclopramide were compatible and stable for at least 32 days at 4°C and can be prepared in advance in a centralized intravenous additive service facility.