RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR NITAZOXANIDE IN POWDER FOR SUSPENSION DOSAGE FORM

摘要

A simple, precise, accurate, rapid and reproducible RP-HPLC method has been developed for the determination of Nitazoxanide in powder for suspension dosage form. Chromatography was carried out on an ODS C18 column (250 x 4.6 mm x 5 μm length), using a mixture of acetonitrile and 0.005 mol L-1 tetra n- butyl ammonium hydrogen sulphate (54:46 v/v) as the mobile phase at a flow rate of 1 mL/min and the detection was done at 240 nm. The method produced linear responses in the concentration range from 50 to 150 μg/mL of Nitazoxanide with correlation coefficients of 0.999, accuracy of 98.90% and precision of 0.811%. The method was found to be reproducible for analysis of the drug in suspension dosage form. The results of the analysis were tested and validated statistically for various parameters according to ICH guidelines and recovery studies confirmed the accuracy of the proposed method.