Validated HPLC Method for Simultaneous Determination of Metronidazole Benzoate, Diloxanide Furoate, and Paraben Preservatives in Combined Formulations
Abstract
Objective: To develop and validate a simple, precise, and stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of metronidazole benzoate, diloxanide furoate, methylparaben, and propylparaben in a combined pharmaceutical suspension. Results: Chromatographic separation was achieved on a C18 column (4.6 × 150 mm, 5 µm) using an isocratic mobile phase consisting of ammonium acetate buffer (pH 7.0), methanol, and acetonitrile, with photodiode array detection at 254 nm. All analytes were well resolved within 12 minutes. The method was validated according to ICH Q2(R1), GEON, and U.S. FDA ORA guidelines. It demonstrated excellent linearity (R² > 0.999), satisfactory accuracy (recoveries within acceptable limits), and high precision (%RSD ≤ 1.1%). The limits of detection and quantification confirmed adequate sensitivity. The method was found to be robust and specific, with no interference from excipients or degradation products under stress conditions. This validated method is suitable for routine quality control and stability testing of pharmaceutical formulations containing these compounds.
Citation Information
@article{ibrahimsharhan2026,
title={Validated HPLC Method for Simultaneous Determination of Metronidazole Benzoate, Diloxanide Furoate, and Paraben Preservatives in Combined Formulations},
author={Ibrahim Sharhan and Wafa M. Al‑Madhagi and Ahmed M. Sabati and Ammar AL-Farga},
journal={BMC Research Notes},
year={2026},
doi={https://doi.org/10.21203/rs.3.rs-9304498/v1}
}
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