STABILITY OF REFRIGERATED AND FROZEN-SOLUTIONS OF TROPISETRON IN EITHER POLYVINYLCHLORIDE OR POLYOLEFIN INFUSION BAGS

Objective: To investigate the stability of 50 mu g/ml tropisetron in 0 .9% sodium chloride or 5% dextrose injections on storage in either 100 ml polyvinylchloride (Tuliflex(R)) or polyolefin (Clear-flex(R)) infu sion bags, at +4 degrees C and -20 degrees C. Method: A stability-indi cating high-performance liquid chromatography (HPLC) assay was used to measure residual drug at day 0 (D0), D8, D15, D30, D60 and D90 for ea ch bag. Samples were tested for PH at D0, D60 and D90. Frozen samples were thawed in a microwave oven according to a validated procedure bef ore analysis. Results: In 0.9% sodium chloride and 5% dextrose, no deg radation products were observed in any of the chromatograms. No admixt ures, at any time, contained less than 98.2% of the initial concentrat ion. Only minor changes (-0.12 unit) in pH occurred over the storage p eriod. No colour or other visual changes were seen in any sample. Conc lusion: Tropisetron (50 mu g/ml) in either 0.9% sodium chloride or 5% dextrose is chemically stable in polyvinylchloride or polyolefin bags for at least 3 months when stored in a refrigerator or in a frozen sta te.