STABILITY STUDY OF EPIRUBICIN IN NACL 0.9-PERCENT INJECTION

OBJECTIVE: To determine the stability of epirubicin in NaCl 0.9% injec tion under hospital storage conditions. METHODS: NaCl 0.9% solution wa s added to epirubicin lyophilized powder to make a final concentration of 1 mg/mL to study the degradation kinetics and 2 mg/mL to study the stability in polypropylene syringes under hospital conditions. SETTIN G: Physical chemistry laboratory, Unitat de Fisicoqufmica, Universitat de Barcelona. MAIN OUTCOME MEASURES: Solutions of epirubicin at 2 mg/ mL in NaCl 0.9% solutions stored in plastic syringes were studied unde r hospital conditions at room temperature (25 +/- 1 degrees C) and und er refrigeration (4 +/- 1 degrees C) both protected from light and exp osed to room light (similar to 50 lumens/m(2)). All samples were studi ed in triplicate and epirubicin concentrations were obtained periodica lly throughout each storage/time condition via a specific stability in dicating HPLC method. To determine the degradation kinetics,solutions of epirubicin in NaCl 0.9% at 1 mg/mL were stored at different tempera tures (40, 50, and 60 degrees C) to obtain the rate degradation consta nt and the shelf life at room temperature and under refrigeration. RES ULTS: The degradation of epirubicin in NaCl 0.9% solutions follows fir st-order kinetics. The shelf life was defined as the time by which the epirubicin concentration had decreased by 10% from the initial concen tration. In this study, epirubicin was stable in NaCl 0.9% injection s tored in polypropylene containers for all time periods and all conditi ons. That results in a shelf life of at least 14 and 180 days at 25 an d 4 degrees C, respectively. The maximum decrease in epirubicin concen tration observed at 25 degrees C and 14 days was 4%, and at 4 degrees C and 180 days was 8%. The predicted shelf life obtained from the Arrh enius equation was 72.9 +/- 0.2 and 3070 +/- 15 days at 25 and 4 degre es C, respectively. in both dark and illuminated conditions. CONCLUSIO NS: Solutions of epirubicin in NaCl 0.9% at 2 mg/mL are chemically sta ble when they are stored in polypropylene syringes under hospital stor age conditions. No special precaution is neccessary to protect epirubi cin solutions (2 mg/mL) from light.