Determination of Temafloxacin, Sarafloxacin, and Difloxacin in Bulk Drug and Dosage Forms by High-Performance Liquid Chromatography

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Abstract
The fluoroquinolones, temafloxacin, sarafloxacin, and difloxacin, are determined in the bulk drug substances and in a variety of dosage forms using high-performance liquid chromatography (HPLC). The HPLC system used is also applicable for ciprofloxacin and norfloxacin. The procedure uses UV detection at 280 nm, which provides a linear response of the subject compounds to at least 20 µg/ml. Assay precision (RSD) values were ±1.2% or better for the bulk drugs and ranged from ±0.42 to ±2.3% for suspension, capsule, and tablet formulations. Drug recoveries were quantitative from the dosage forms tested. Sensitivity of the subject compounds is approximately 50 ng/ml (2.5 ng on column).

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