RP-HPLC method development and validation for the estimation of furazolidone in bulk and pharmaceutical dosage form

Abstract:A reversed-phase high-performance liquid chromatography (RP-HPLC) method wasdeveloped and validated for the estimation of Furazolidone in bulk and tablet dosage forms.The separation was achieved on a Princeton C18 analytical column (150 mm × 4.6 mm i.d.,5.0 μm) acetonitrile: [trimethylamine (0.02% in water)] (65:35), as mobile phase, and at aflow rate of 1.0 ml/min. The detection was carried out using a PDA detector at 366 nm. Thetotal chromatographic analysis time per sample was about 6.0 min, with FUR eluting at aretention time of about 1.76±0.3 min. The method was validated for accuracy, precision,specificity, linearity, and sensitivity as per ICH guidelines. The standard curve was linearover the concentration range of 5-25 μg/ml with R2 value 0.9991. The limit of detection(LOD) and limit of quantitation (LOQ) obtained for FUR were 0.39 μg/ml and 1.32 μg/mlrespectively. The developed and validated method was successfully applied for thequantitative analysis of FUR in a 100 mg Tablet. The high recovery and low retention timeconfirm the suitability of the proposed method for the determination of FUR in regular assayand quality control analysis.