Abstract
A sensitive RP HPLC method has been developed and validated for the determination of ofloxacin and flavoxate hydrochloride in spiked human plasma. For the estimation of drugs in plasma, sample pretreatment involved only protein precipitation by acetonitrile. Chromatographic separation was performed on a Kromasil C
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(4.6 mm × 250 mm, 5 µm) column, with mobile phase consisting of formic acid in water, methanol, and acetonitrile using gradient elution with a flow rate of 1 mL/min at wavelength 311 nm. The method was validated according to ICH guidelines. The calibration curves were linear with a correlation coefficient more than 0.999 over a concentration range of 13 ng/mL to 2000 ng/mL for ofloxacin and 25 ng/mL to 2000 ng/mL for flavoxate HCl. The results demonstrated that the procedure is accurate, precise, and reproducible, while being simple; it can be suitably applied for the evaluation of pharmacokinetic profiles of ofloxacin and flavoxate HCl in humans.