Chemometric-Assisted UV Spectrophotometric Determination of Metronidazole and Diloxanide Furoate in Binary Pharmaceutical Formulations
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Abstract
This study introduces simple, rapid, accurate, precise, and environmentally friendly spectrophotometric approaches for the simultaneous determination of Metronidazole (MNZ) and Diloxanide Furoate (DLF) in laboratory-prepared mixtures and combined pharmaceutical formulations. The proposed method employs the Partial Least Squares (PLS) chemometric technique, which successfully eliminates the need for prior chemical separation steps. This approach aligns with Green Analytical Chemistry (GAC) principles, offering a significantly greener alternative by avoiding the consumption of hazardous organic solvents and reducing overall analysis time and waste generation compared to the established High-Performance Liquid Chromatography (HPLC) reference. Calibration models were developed over concentration ranges of 8-24 μg mL for MNZ and 3-12 μg/mL for DLF. Spectral data for 25 mixtures containing varying ratios of both drugs were recorded in the range of 240-320 nm. The PLS model demonstrated significant superiority and robustness in resolving the severe spectral overlap between the two analytes and effectively managing the complexity of the pharmaceutical matrix, a challenge that compromises conventional univariate methods. The developed methodology was fully validated according to ICH guidelines, exhibiting excellent linearity, precision, and accuracy. Mean percentage recoveries for MNZ and DLF in the pharmaceutical formulation were found to be highly satisfactory, indicating minimal matrix interference.
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