RP-HPLC Determination of Nitazoxanide in Bulk and Different Tablet Formulations

Abstract

A simple, accurate and precise validated RP-HPLC method for determination of
Nitazoxanide has been developed. Analysis was carried out on Jasco HPLC system with HiQ-sil
C18 column (250 x 4.6 mm i.d.) using Acetonitrile: 0.005 mol.L–1 Tetrabutyl ammonium hydrogen
sulphate in ratio of 55:45 v/v as mobile phase and Satranidazole as an internal standard The
detection was carried out using UV detector set at 240 nm. For this method, Beer’s law is
obeyed in the concentration range of 5.0 to 30.0 Çg mL–1
of Nitazoxanide. The developed
method has been successfully applied for the analysis of drug in bulk and pharmaceutical
formulations. The mean percent recoveries were found to be 100.19 É 0.584 for Brand 1 and
100.26 É 1.1341 for Brand 2. The method was validated with respect to linearity, precision and
accuracy as per the International Conference on Harmonisation (ICH) guidelines.