Analytical Method Development and Validation of Nitazoxanide by RP-HPLC Method in API and Tablet Dosage Forms

A Simple, precise and accurate RP-HPLC method was developed for determination of of Nitazoxanide in API and tablet dosage forms. The chromatographic separation was done on Cosmosil C18 Column (250mm x 4.6mm,5µm) using mobile phase MEOH+ 0.05% (OPA with TEA) Water (70+30% v/v) at flow rate 0.7ml/min and wavelength detection 340nm.The retention time for Nitazoxanide was found to be 4.333 min. Linearity was observed in the range10-50μg/ml (y=55.38x-37.01 and R² = 0.9976). The LOD and LOQ was found to be 0.4258 and 1.289 respectively. The Precision as indicated by repeatability study was having %RSD less than 2. The accuracy, intraday and interday were also found to be less than 2. Hence the proposed method is successfully developed and validated.