International Journal For Multidisciplinary Research

E-ISSN: 2582-2160   •   Impact Factor: 9.24

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Development of a Novel Stability Indicating HPLC Method for the Simultaneous estimation of Cefepime and Enmetazobactam in Dosage Form Using Response Surface Methodology

Author(s) H. Neelofar, Dr. D. Ranganayakulu
Country India
Abstract The current study highlights the systematic quality by design assisted creation of an efficient analytical technique for the estimation of Cefepime and Enmetazobactam in EXBLIFEP intravenous (IV) infusions form. Response surface methodology in the design of experiments was used for identifying key material attributes and critical process parameters that influence the designated critical analytical attributes. Separation was achieved on the Sunfire C18 column (250x 4.6 mm, 5µm). The effects of acetonitrile content (v/v), flow rate, and column temperature on the retention times of the two drugs and their resolution and the number of theoretical plates were investigated and optimized. The optimum chromatographic conditions within the design space were found to be an isocratic mobile phase consisting of water and acetonitrile (50: 50, v/v) with a flow rate of 1mL/min and a run time of 6 min. The retention times of Cefepime and Enmetazobactam were found to be 2.36-min and 2.98-min. Different validation parameters were established, and the approach was validated in agreement with the ICH and FDA requirements. Data analysis using statistical methods has revealed that the method is reliable, accurate, and robust.
Keywords Design of Experiments, Response Surface Methodology, Central Composite Design, Critical Analytical Attributes, Design-Expert 10.0.2 Software
Published In Conference / Special Issue (Volume 8 | Issue 1) - National Conference on Sciences, Pharmacy, Humanities & Commerce, Engineering for Research and Education (SPHERE-2025) (February 2026)
Published On 2026-02-01
DOI https://doi.org/10.36948/ijfmr.2026.SPHERE-2025.1516
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E-ISSN 2582-2160
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