Abstract

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 (r2 = 0.9977) for cefepime and 0.5–3.0 µg/mL (r2 = 0.9974) 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.

Highlights

  • Cefepime hydrochloride (CEFE) is fourth-generation, semisynthetic, broad spectrum, cephalosporin antibiotic for parenteral administration

  • By using optimized chromatographic conditions, CEFE and Tazobactam sodium (TAZO) were eluted at 9.97 min and 7.61 min, respectively (Figure 2)

  • The assay result of CEFE and TAZO in pharmaceutical dosage form was comparable with the value claimed on the vial

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Summary

Introduction

Cefepime hydrochloride (CEFE) is fourth-generation, semisynthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. It is 1-[[(6R, 7R)-7-[2-(2Amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia1-azabicyclo [4.2.0] oct-2-en-3-yl] methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate (Figure 1). 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 complicated intra-abdominal infection. Till date no chromatographic method is available for simultaneous estimation of CEFE and TAZO in combination. It was thought to develop simple RP-HPLC method for simultaneous estimation of CEFE and TAZO in bulk as well as in pharmaceutical formulation

Experimental
Preparation of Standard Stock Solution
Analysis of Laboratory Mixture
Assay of Marketed Formulation
Results
Validation
Discussion
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