Simultaneous Determination of Cefepime and Tazobactam in Injectables by Ultra-High Performance Liquid Chromatography Method
Aim: Stability indicating ultra-high performance liquid chromatography (UHPLC) method was developed and validated for the determination of cefepime (CFPM) and tazobactam (TZB) in injectable dosage form. Materials and Methods: Separation was performed in a Dionex Ultimate 3000 UHPLC system equipped with chromeleon software using Acclaim 120 C18 (250 × 4.6 mm, 5 μm particle size) column with mobile phase (pH 6.0) containing methanol and sodium acetate buffer in the ratio of 11:89 v/v with a flow rate of 1.8 mL/min and detection wavelength of 220 nm. Stress studies were performed using HCl, NaOH, H2O2, and ultraviolet radiation. Results: The method was found to be linear in the concentration range of 50-350 μg/ml (R2 = 0.998) and 6.25-43.75 μg/ml (R2 = 0.998) with the regression equation y = 11068 x + 115231 and y = 8317.1x – 9869.7 for CFPM and TZB, respectively. The percentage of relative standard deviation (%RSD) of 0.63 and 1.39 for intra-day and 0.64 and 0.54 for inter-day precision, respectively for CFPM and TZB suggest the precision of the method as all these values are <2%. It was found from the stress studies that both the drugs are very susceptible to alkaline condition. The method has shown good, consistent recoveries for CFPM (100.6-102.0%) with mean RSD of 0.73% and TZB (98.4-100.6%) with mean RSD of 1.14%, which indicates the method is sufficiently accurate. Conclusion: The method was found to be accurate, precise, specific, robust, linear, and stability indicating for the determination of CFPM and TZB in injectable dosage form.