Original Articles: 2013 Vol: 5 Issue: 11
A validated reverse phase high performance liquid chromatographic assay method for the estimation of iloperidone in bulk and commercial tablet dosage form
Abstract
A simple, rapid, accurate, precise and sensitive reverse phase HPLC method was developed and validated for the estimation of Iloperidone in bulk and pharmaceutical dosage form. The chromatographic separation was achieved by isocratic mode of elution by using Sunfire C18 (50 x 4.6 mm, particle size 3.5 μm) column and mobile phase consisting of phosphate buffer (0.02 M KH2PO4, adjusted to pH 3.65 with triethylamine) and acetonitrile in the ratio of 72:28 % v/v was used with a flow rate of 1 ml/min and the analyte was monitored at 230 nm. The retention time was found to be 3.185 min. The developed method was validated as per ICH guidelines. The calibration curve of Iloperidone was linear over the range of 7.5 - 45 μg/ml with correlation coefficient of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 1.02μg/ml and 3.44 μg/ml respectively. The % recovery of Iloperidone in tablet dosage form was found to be 99.24 %. The method can be utilized for quantitative determination of Iloperidone in bulk and pharmaceutical dosage form.