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August 29, 2026Open Access

Rp-HPLC Method for Quantification of Cefixime and Ofloxacin Anti-Bacterial Agent in Bulk Material and Pharmaceutical Formulation

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Authors

MBMs. Gayatri Kailash Awachar, Dr. Sunil S Jaybhaye, Dr. Sandip V Phoke, Dr. Tharun Kumar Gandapuram, Mr. Hatkar A. D , Mr. Y. P Muley, Mr. Tejas Mudhal, Ms.Prajakta Anil Bhumare

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Overview

Analytical validation study demonstrates rapid simultaneous quantification of cefixime and ofloxacin in formulations, indicating suitability for routine pharmaceutical quality control.

Key Points

  • To develop and validate a rapid, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of cefixime and ofloxacin in bulk drug substances and tablets.
  • Separation was performed on a Fortis C18 column (150 mm × 4.6 mm, 2.5 μm) using a mobile phase of acetonitrile and 0.05% orthophosphoric acid buffer (pH 6.5) at an 80:20 (v/v) ratio.
  • The mobile phase was delivered at 1.0 mL/min with UV detection at 286 nm.
  • The method was validated according to ICH guidelines across linearity ranges of 5–25 μg/mL for cefixime and 40–200 μg/mL for ofloxacin.
  • Retention times were 5.70 min for cefixime and 3.04 min for ofloxacin within a total run time under 6 minutes, yielding linearity correlation coefficients (R²) of 0.9999 and 0.9996, respectively.
  • Mean recoveries ranged from 99.54% to 100.99% for cefixime and 99.52% to 99.70% for ofloxacin, with relative standard deviation (%RSD) values below 2% demonstrating high precision.
  • Limits of detection and quantification were 0.66 μg/mL and 1.84 μg/mL for cefixime, and 2.11 μg/mL and 6.40 μg/mL for ofloxacin, with tablet assay recoveries close to 100%.

Cite This Study

Ms. Gayatri Kailash Awachar, Dr. Sunil S Jaybhaye, Dr. Sandip V Phoke, Dr. Tharun Kumar Gandapuram, Mr. Hatkar A. D , Mr. Y. P Muley, Mr. Tejas Mudhal, Ms.Prajakta Anil Bhumare (2026) studied this question.

synapsesocial.com/papers/6a9299958e5d7d1fc0c11a1dhttps://doi.org/10.5281/zenodo.22122066
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