ISOCRATIC RP-HPLC, UV METHOD DEVELOPMENT AND VALIDATION OF ITRACONAZOLE IN CAPSULE DOSAGE FORM

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Itraconazole in capsule dosage form. An inertsil C-18, 5 mu m column having 250 x 4.6mm internal diameter in isocratic mode with mobile phase containing Tetrabutyl ammonium hydrogen sulphate buffer solution and Acetonitrile in the ratio of 40: 60v/v was used. The flow rate was 1.5ml/min and effluents were monitored at 225nm. The retention time for Itraconazole was 5.617min. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection and limit of quantification were found to be 0.85 mu g/ml and 2.60 mu g/ml respectively and recovery of Itraconazole from capsule formulation was found to be 98.3 to 100.3%. The system suitability parameters such as theoretical plates and tailing factor were found to be 2927.43 and 1.08 The proposed method was successfully applied for the quantitative determination of Itraconazole in capsule formulation.