Abstract

A Validated RP-HPLC Method for the Assay of Prulifloxacin in Marketed Drug Product using Levofloxacin as an Internal Standard

Author(s): P. Ravisankar, G. Devala Rao, Ch. Devadasu, G. Sudhakar Saibabu and P. Srinivasa Babu

A simple, accurate, precise, specific isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative estimation of prulifloxacin in pharmaceutical formulations. RP-HPLC method was developed by using Welchrom C-18 Column (4.6 x 250 mm, 5 μm), Shimadzu LC-20AT prominence liquid chromatograph. The mobile phase used is phosphate buffer (pH-3.2): acetonitrile (60 : 40 v/v) with a flow rate of 1 mL/min. The responses are measured at 285 nm using Shimadzu SPD-20A prominence UV-Vis detector. Levofloxacin is used as internal standard. The retention times of prulifloxacin and levofloxacin are found to be 7.093 and 2.780 min respectively. The method posses linearity in the range of 2-12 μg/mL. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of prulifloxacin in tablet dosage forms.