Stability study of epirubicin hydrochloride solutions for injection prepared from three different formulations / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the stability of epirubicin hydrochloride solutions for clinical use prepared from three different formulations (one concentrated solution and two powders for injection). METHODS: Epirubicin hydrochloride in three formulations was dissolved or diluted in 0.9% sodium chloride to prepare the test solutions with concentration of 0.4mg · mL-1. These solutions were stored at different temperatures and under different shading circumstances, and samples were collected periodically during the storage to evaluate the stability, including visual inspection, pH value and content of epirubicin. RESULTS: All epirubicin solutions were stable when stored at 2-8°C under dark condition for 40 d with average content of greater than 93.76%. When stored atroom temperature with or without light exposure for 40 d, only the solution diluted from the concentrated water solution for injection was stable, as the average content remained above 92.57%. While the solutions prepared from the other two powders for injection were not stable, as the average content fell below 90% at room temperature after 2-7 d. CONCLUSION: Epirubicin solutions prepared from three different formulations are stable when stored either at 2-8°C under dark condition for 40 d or at room temperature for 24 h. The solution prepared from the concentrated water solution for injection is more stable than the solutions prepared from the two powders for injections when stored at room temperature for a long period (40 d).