Determination of Itraconazole in Bulk and Capsule Dosage Form by a Validated Isocratic RP-HPLC Method

Abstract

Itraconazole is potent triazole anti-fungal agent that is prescribed to patients with fungal infections for the treatment of mycoses. In the present study a RP-HPLC method was developed and validated for the assay of itraconazole in bulk and its pharmaceutical dosage forms. The chromatographic system was equipped with Zorbax C18 column (150× 4.6 mm, 5μm). The HPLC system used was Agilent 1100 series. The detection was carried out using PDA detector at 262 nm with a mobile phase composition of acetonitrile and water in the ratio (75:25%v/v) at a flow rate of 1.0 ml/min and the injection volume was 10 μl with 7 minutes runtime. The proposed method was linear over a concentration range of 4–40 μg/ml for the assay of itraconazole with a correlation coefficient of 0.9993. The retention time of itraconazole was found to be 3.753 min. The limit of detection and limit of quantification was found to be 0.624 μg/ml and 2.26 μg/ml respectively. The parameters of analysis were validated as per ICH guidelines. The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate, which is useful for the routine estimation of itraconazole in bulk and pharmaceutical dosage forms.