STABILITY OF PACLITAXEL WITH ONDANSETRON HYDROCHLORIDE OR RANITIDINE HYDROCHLORIDE DURING SIMULATED Y-SITE ADMINISTRATION

The stability of paclitaxel with either ondansetron hydrochloride or r anitidine hydrochloride during simulated Y-site injection at room temp erature was studied. Triplicate test solutions of paclitaxel 0.3 and 1 .2 mg/mL were admired 1:1 with ondansetron 0.03 and 0.3 mg/mt (as the hydrochloride salt) or ranitidine 0.5 and 2.0 mg/mL (as the hydrochlor ide salt). Also, paclitaxel 1.2 mg/mt was admired 1:1:1 with ondansetr on 0.3 mg/mL and ranitidine 2.0 mg/mL. The solutions were stored in gl ass containers at room temperature, and samples were removed at zero, one, two, and four hours for immediate assay. At the time of the assay and before any dilution, each sample was visually inspected for clari ty, color, and precipitation, and the pH was determined. Drug concentr ations were measured by stability-indicating high-performance liquid c hromatographic procedures. Throughout the study, more than 90% of the initial concentrations of paclitaxel, ondansetron, and ranitidine rema ined in the solutions. No precipitates, color changes, or haziness was seen. The changes in pH were minor. Paclitaxel in concentrations of 0 .3 and 1.2 mg/mL was stable when mixed with either ondansetron (0.03 o r 0.3 mg/mL, as the hydrochloride salt) or ranitidine (0.5 or 2.0 mg/m L, as the hydrochloride salt) and stored in glass containers for four hours. Paclitaxel 1.2 mg/mL was also stable when mixed with both ondan setron 0.3 mg/mL and ranitidine 2.0 mg/mL and stored in glass containe rs for four hours.