Development of UV-spectrophotometric method and its validation for estimating contents of Prulifloxacin in Simulated Intestinal Fluid

Abstract

This study was performed with an objective of developing and validating an UV-spectroscopic method for estimating contents of prulifloxacin in simulated intestinal fluid (SIF) i.e. phosphate- buffer media with a pH of 6.8 as per ICH guidelines. The λmax for prulifloxacin in phosphate- buffer media pH 6.8 was found to be 272 nanometer. The calibration curve of drug followed linearity in-between 1-9 μg/ml concentration range and correlation co-efficient value was found equal to 0.9995. We tested this proposed method onto the bulk and marketed pharmaceutical formulation (tablets) also in order to find out contents of drug. Using developed method for estimation of prulifloxacin in SIF, drug was found to be in-between 101.91 and 104.02 % in marketed tablets which shows a good agreement with that of the claimed level. Accuracy of developed method was established through recovery experimentation, performed for three spiked percent concentrations- 75%, 100%, and 125%. The % recovery was found to be in between 97.27 and 101.82%. Low values of % RSD supported accuracy as well as the reproducibility of developed method. Precision of developed method was established by good in-limit intraday and interday experimental variations and through repeatability tests. Values of % RSD less than 2 confirmed about precision of developed method. The ruggedness of the developed method was validated by performing drug estimation by two different performers. This proposed spectroscopic method has proved to be a rapid and successful method for routine analysis of prulifloxacin in simulated intestinal fluid.