Abstract
A simple, sensitive, linear, precise and accurate RP-HPLC method for the simultaneous estimation of Cefepime Hydrochloride and Tazobactam Sodium in sterile dry powder for injection was developed and validated. The chromatographic separation of the two drugs was achieved on Inertsil ODS 3V (150 mm x 4.6 mm) 5µ column in a Gradient mode. The mobile phase mixture consisting of 0.08 M ammonium acetate buffer whose pH was adjusted to 3.0 using dilute orthophosphoric acid (solvent A) and acetonitrile (solvent B) was set with gradient programming for 15min and was delivered at a flow rate of 0.8 mL/min and effluents are monitored at 220 nm. The retention time of Cefepime HCL and Tazobactam Sodium was found to be 3.722 and 4.304 min respectively. The percentage assay of Cefepime HCL and Tazobactam Sodium was found to be 99.83% and 96.51%. Calibration curves were linear with a correlation coefficient of 0.991 for CEH and 0.997 for TAS over the concentration range of 40-120 μg/mL for both the drugs and precise with (%RSD<2). The LOD for CEH and TAS were found to be 0.2 μg/mL and 0.022 μg/mL and LOQ for CEH and TAS were found to be 0.6 μg/mL and 0.075 μg/mL respectively. The method was validated by determining its accuracy, precision and system suitability as per ICH guidelines and the developed method can be employed for routine quality control analysis.
