RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF KETOCONAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, precise, economic and accurate isocratic RP-HPLC method has been developed and subsequently validated for the determination of Ketoconazole in bulk and pharmaceutical dosage forms as per ICH guidelines. The separation achieved on a reversed phase Phenomenex Luna C18, 100A, 5mm, 250mmx4.6mm i.d. as a stationary phase and Acetonitrile: Phosphate buffer in the ratio of 68:32v/v as mobile phase at a flow rate of 1.0 ml/min. The UV detection was performed at 242 nm. The retention time for Ketoconazole was found to be 4.768min. The detector response was linear in the concentration range of 0-14 µg/ml. The %RSD for precision and accuracy of the method was found to be less than 2%. The respective linear regression equation being Y= 72353.x + 5437 with R2 = 0.999. The limit of detection and the limit of quantification were found to be 0.08µg/ml and 0.26µg/ml respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, LOD and LOQ. The results of the study showed that, the proposed RP-HPLC method was simple, rapid, precise, accurate and stability indicating, which can be used for the routine determination of Ketoconazole in bulk and its pharmaceutical dosage form.