RP-HPLC Method for Simultaneous Estimation of Cefepime Hydrochloride and Tazobactam Sodium in Bulk and Pharmaceuticals

A precise, accurate, sensitive and robust RP-HPLC method was developed for cefepime hydrochloride and tazobactam sodium in bulk and pharmaceutical formulation. Chromatographic separation was achieved on PrincetonSPHER-100 C-18 column (250？mm？×？4.6？mm i.d., 5？μm) at ambient temperature. A binary mobile phase consisting of 25 mM potassium dihydrogen phosphate buffer, pH 6.2 and acetonitrile (94？:？6, v/v) was delivered through a column at a flow rate of 1？mL/min. Measurement was performed at a wavelength 210？nm. The method was linear over the concentration range of 4–24？μg/mL ( ) for cefepime and 0.5–3.0 μg/mL ( ) for tazobactam. The percentage content found for cefepime was 101.12？±？0.49 and for tazobactam was 101.33？±？1.17 in the pharmaceutical formulation. The method was validated for linearity, precision, accuracy, sensitivity and robustness as per ICH Q2 (R1) guideline. 1. Introduction Cefepime hydrochloride (CEFE) is fourth-generation, semisynthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. Chemically, it is 1-[[(6R, 7R)-7-[2-(2-Amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo oct-2-en-3-yl] methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate (Figure 1). CEFE is a zwitterionic oxymino β-lactam with an amino-thiazole side chain, which enhances the ability of CEFE to penetrate rapidly the outer cell membrane of gram-negative bacteria. CEFE used in the treatment of moderate-to-severe infections such as pneumonia, uncomplicated urinary tract infections, skin and soft tissue infections, intra-abdominal infections and febrile neutropenia. Figure 1: Chemical structure of (a) cefepime (b) tazobactam. Tazobactam sodium (TAZO) is chemically known as (2S, 3S, 5R)-3-methyl-7-oxo-3-(1H-1, 2, 3-triazol-1-ylmethyl)-4-thia-1-azabicyclo heptane-2-carboxylic acid 4,4-dioxide (Figure 1). TAZO is semisynthetic parenteral penicillin. TAZO is a β-lactamase inhibitor with a broad spectrum of antibacterial activity against most gram positive, gram negative aerobic bacteria and anaerobic bacteria. Megapime XP is a sterile combination of CEFE and TAZO available as a dry powder for injection. The fixed dose combination of CEFE and TAZO is used parenterally for the treatment of moderate to severe infection caused by or suspected of being caused by susceptible β-lactamases producing bacteria, while CEFE alone would be ineffective. CEFE and TAZO combination used for the treatment of uncomplicated and complicated urinary tract infection, uncomplicated skin and skin structure infection and