Development and Validation of UV-Visible Spectrophotometric Method for the Analysis of Cefepime in Pharmaceutical Formulations

Abstract

A simple, sensitive, selective rapid spectrophotometric method has been developed for the determination of Cefepime in pure form and pharmaceutical formulations based on the oxidative coupling reaction with MBTH reagent, at PH_4.0 which is extractable at 610 nm. Beer’s law is obeyed in the concentration ranges 5-30 µg ml-1. The developed method was applied directly and easily for the analysis of the Pharmaceutical formulations. R.S.D was found to be 0.2604% and Recovery 98.65% respectively. The method was completely validated and proven to be rugged. The interferences of the other ingredients and excipients were not observed. The repeatability and the performance of the proved method were established by point and internal hypothesis and through recovery studies.

Introduction

Cefepime is a fourth-generation cephalosporin antibiotic with broad-spectrum activity against both Gram-positive and Gram-negative bacteria. Its chemical formula is C??H??N?O?S? with a molecular weight of 480.54 g/mol. It works by killing or inhibiting bacterial growth but is ineffective against viral infections like the flu.

The study aimed to develop a simple, accurate, and validated UV-Visible spectrophotometric method for the quantitative estimation of Cefepime in its technical grade, pharmaceutical formulations, and biological samples (e.g., blood).

Key analytical features include:

• Functional group for detection: Primary amine of Cefepime.

• Color development: Based on an oxidative coupling reaction with MBTH (3-methyl-2-benzothiazolinone hydrazone) and Ferric chloride, forming a stable orange-red chromogen measured at 610 nm.

• Solvent: Dimethyl sulfoxide (DMSO) was used throughout.

• Sample preparation: Included precise dilution and heating steps for tablets and blood samples.

• Validation parameters: Ensured accuracy, precision, repeatability, and reproducibility.

The method enables reliable quantification of Cefepime in multiple matrices, providing a valuable tool for quality control and pharmacokinetic studies.

Conclusion

The proposed method can be used for determination of Cefepime in Formulations. The method is rapid, simple and has great sensitivity and accuracy. Proposed method makes use of simple reagents, which an ordinary analytical laboratory can afford. Method is sufficiently sensitive to permit determination even down to 10µg ml-1 . The proposed method is suitable for routine determination of Cefepime in its formulation and Blood. The commonly used additives such as Starch, Lactose, Titanium dioxide, and Magnesium state do not interfere with the assay procedures.

References

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Copyright

Copyright © 2025 Dr. P. Suguna. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.