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Development and Validation of New RP-HPLC Method for the Estimation of Prulifloxacin in Pharmaceutical Dosage Forms

P. Ravisankar, Ch. Devadasu, P. Srinivas Babu, G. Devala Rao and S. Gananathamu

A simple, accurate and precise RP-HPLC method has been developed for the quantitative estimation of prulifloxacin in pharmaceutical formulations. Prulifloxacin is a prodrug, and is metabolized in the body to the active compound ulifloxacin. Prulifloxacin appeared as effective as ciprofloxacin, coamoxiclav or pefloxacin in the treatment of bronchitis exacerbations or lower urinary tract infections. A RP-HPLC method was developed by using a Phenomenex Luna C18 column (250 mm length, 4.6 mm internal diameter and 5?m particle size) and a 60 : 40 v/v mixture of 10 mM phosphate buffer (pH adjusted to 3.0 after addition of 2.5 mL of triethyl amine) and acetonitrile was used as mobile phase. The analyte was monitored with UV detector at 275 nm. Typical retention time for prulifloxacin was found to be 6.8 min. The method was statistically validated for its linearity, accuracy and precision. Due to its simplicity and accuracy, the method can be used for routine quality control of prulifloxacin in pharmaceutical formulations.