RP-HPLC methods for estimation of Nitazoxanide single and simultaneous estimation of Nitazoxanide with Ofloxacin in pharmaceutical dosage forms

Two simple, selective, rapid, precise and economical reverse phase high-pressure liquid chromatography methods have been developed; first method for estimation of nitazoxanide and second method for simultaneous estimation of nitazoxanide & ofloxacin from pharmaceutical dosage forms. The first method carried out on a Hypersil BDS C8 column (5μ particles size) (250 mm X 4.6 mm), with mobile phase consisting of acetonitrile: 0.2M potassium dihydrogen phospate in ratio 70:30 (pH 3.0 adjusted with orthophosphoric acid) at a flow rate of 1.0ml/min. Detection was carried out at 319nm. The retention time of nitazoxanide was 4.51 min. First developed method cannot easily apply for the simultaneous estimation of nitazoxanide and ofloxacin. So second method carried out on same column but different mobile phase which consisting the acetonitrile: 0.2M potassium dihydrogen phospate: methanol in ratio 70:10:20 (pH 3.5 adjusted with orthophosphoric acid) at a flow rate of 1.0ml/min. Detection was carried out at 302nm. The retention time of nitazoxanide and ofloxacin were 6.93 min and 9.32 min, respectively. The results of analysis shows that the amounts of drugs were in good agreement with the labelled claim of the formulations. The method validation parameters checked as per the ICH guidelines. Thus the methods are specific and sensitive.