Abstract
Aminoglycosides are antibiotics with high clinical importance that face a great challenge of detection in the UV range. This study aimed to develop an accurate, simple, and sensitive validated high-performance liquid chromatographic (HPLC) method for the determination of amikacin sulfate, one of the widely used aminoglycoside antibiotics in the pharmaceutical formulations, as the target analyte without interference from its preservation additive sodium metabisulfite in the pharmaceutical dosage forms without the usage of any derivatization reactions. The developed method is based on direct UV detection at 205 nm using a gradient mobile phase consisting of acetonitrile as an organic solvent and buffered solution; pH 3.0. This method was developed on a reversed-phase ZORBAX ECLIPSE XDB-C8 (4.6 × 250 mm, 5-μm) analytical column with a flow rate of 1.5 mL min−1 at a column temperature of 35 °C. The separation of amikacin sulfate and sodium metabisulfite was achieved at 3.7, and 1.5 min, respectively. The developed method validation was performed as prescribed by the International Conference on Harmonization (ICH) guidelines to confirm its linearity, precision, and accuracy. Finally, using simple, commonly available analytical tools, safe buffer concentration on the HPLC system, and without any complicated equipment or challenging derivatization steps, our validated HPLC method was applied for the simultaneous determination of amikacin and sodium metabisulfite in commercially available pharmaceutical formulations in a single method of analysis.
Published Version
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