DEVELOPMENT AND METHOD VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFOPERAZONE AND TAZOBACTAM IN MARKETED FORMULATION

Abstract

Objective: A new precise, accurate, sensitive and robust RP-HPLC method was developed for third generation cephalosporin and β lactamase inhibitor i.e. cefoperazone and tazobactam in marketed preparation.

Methods: The Chromatographic separation was achieved on Thermo BDS Hypersil C18 column (250 × 4.6 mm i.d.5 µm) at ambient temperature. A Binary mobile phase consisting of 0.02 mM potassium dihydrogen phosphate buffer, pH 4.0 and Methanol (80:20, v/v) was delivered through a column at a flow rate of 1 ml/min. Measurement was performed at a desired wavelength of 250 nm.

Result: The method was linear over the concentration range of 20-60 µg/mL (r² = 0.9987) for cefoperazone (CEFO) and 2.5-7.5 µg/mL (r² = 0.9998) for tazobactam (TAZO). The percentage content for cefoperazone 97.64±1.0 and of tazobactam was 97.13±0.96 in the marketed formulation. The low value of % Relative Standard Deviation (%RSD) was 0.78 and 0.43 for CEFO and TAZO, respectively, indicates the reproducibility of this method. Tailing Factors for CEFO and TAZO were less than 2. A LOD and LOQ low value suggests the sensitiveness of method. The method was validated for linearity, precision, accuracy, and robustness as per ICH guideline.

Conclusion: It can be concluded from the results that the proposed RP-HPLC method was found to be simple, accurate, robust and precise for the analysis of cefoperazone and tazobactam in bulk and sterile dried injection dosage forms. This method was validated as per ICH guidelines. Thus, it can be used for routine quality control studies for assay of cefoperazone and tazobactam simultaneously.