What does this research mean for the field?

A newly developed RP-HPLC method is simple, rapid, accurate, and precise for the simultaneous quantification of Cefixime and Ofloxacin in bulk and pharmaceutical formulations. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

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.

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

Discussion

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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/6a9299958e5d7d1fc0c11a1d https://doi.org/10.5281/zenodo.22122066

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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

View Full Paper

Ask AI

Bookmark

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

Discussion

Member takes

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

synapsesocial.com/papers/6a9299958e5d7d1fc0c11a1d https://doi.org/10.5281/zenodo.22122066

View Full Paper

Ask AI

Bookmark