Determination of temafloxacin, sarafloxacin, and difloxacin in bulk drug and dosage forms by high-performance liquid chromatography.

The fluoroquinolones, temafloxacin, sarafloxacin, and difloxacin, are determined in the bulk drug substances and in a variety of dosage form 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 micrograms/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).