Analytical Method Development and Validation of S-Nadifloxacin in Pure Form by HPLC

Abstract

A simple, rapid, precise and cost effective HPLC method was developed for S-Nadifloxacin in pure drug and pharmaceutical dosage forms. The separation was carried out using Zorbax SB C18 (150 × 4.6 mm ID. 5 μm particle size) column, with mobile phase comprising of 0.05 %v/v tri fluoro acetic acid and acetonitrile in the ratio of 70 : 30 (v/v). The flow rate was 1.0ml/min and the detection was carried out using UV-visible detector at 237nm. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness, robustness, LOD and LOQ. The retention time were found to be 10.5. Calibration curves were linear with correlation coefficient (r2) 0.999 and concentration range of 0.05 ppm to 5 ppm. The percentage recovery for S-Nadifloxacin was found to be in the range between 98.33- 100.30. Method was found to be reproducible with relative standard deviation (RSD) for intra and inter day precision less than 2%.