Stability Studies of Cefepime Hydrochloride by Stability Indicating RP-HPLC Method

Drug stability and compatibility are critical issues controlling accurate and appropriate delivery of drug therapy to patients. Stability is very important for antibacterial agents especially those given by intravenous route as they reach systemic circulation directly, and the clinical outcome and safety are directly correlated to drug levels in blood. The physical and chemical stability of Cefepime hydrochloride, a fourth generation cephalosporin, was determined at three different temperatures (5 °C/ 60 %RH, 25 °C/60 %RH & 45 °C/75% RH) and quantified by using a stability indicating RP-HPLC method. Decrease in drug concentration by more than 10% from initial concentration (0 time) was considered unstable (chemical instability). Change in pH by more than 1 was considered unstable (Physical instability). The drug solutions were clear and light yellow initially with intensity increasing over time, eventually becoming dark yellow for cefepime. HPLC analysis indicated that 40 mg/ml concentration of cefepime hydrochloride maintained adequate stability for 2 hours at 45°C and up to 24 hours at 25 °C and up to 7 days at 5 °C.