Abstract

ANALYTICAL PROFILING OF CEFEPIME AND TAZOBACTAM: A REVIEW OF RP-HPLC METHODS

Vishal Kumbhar, Vivek B. Panchbhai, *Moein S. Attar, Ram S. Sakhare, Hanuman Hendge, Kedar Dongre, Amar Fulsundar

ABSTRACT

Developing and validating reliable analytical techniques is a cornerstone of pharmaceutical research, directly safeguarding drug safety, quality, and clinical efficacy. This review examines a collection of studies dedicated to creating robust, stability-indicating chromatographic methods capable of simultaneously measuring multiple drugs in both bulk and combination dosage forms. Across the evaluated literature, Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) consistently emerges as the preferred technique, valued for its sensitivity, reliability, and practicality in routine quality control. Methodologically, these studies predominantly utilized C18 columns. Effective separation was typically achieved by fine-tuning mobile phases—combining aqueous buffers with organic solvents like methanol or acetonitrile—and pairing them with UV or Photodiode Array (PDA) detection at optimal absorption wavelengths. Researchers focused heavily on optimizing these methods to ensure clean separation of active analytes from potential impurities, while maintaining sharp peak symmetry and practical retention times. Crucially, all reviewed methods were rigorously validated against standard regulatory guidelines, successfully meeting criteria for accuracy, precision, linearity, robustness, and limits of detection and quantification. The collective results demonstrated excellent reproducibility and high accuracy. Furthermore, by subjecting formulations to forced degradation—including thermal, photolytic, acidic, alkaline, and oxidative stress—these studies proved that the developed RP-HPLC methods can easily distinguish intact active drugs from their degradation products. Ultimately, this body of research underscores RP-HPLC as an exceptionally dependable, fast, and cost-effective tool, ideally suited for everyday pharmaceutical quality control and stability monitoring.

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