Development and validation of a new RP-HPLC method for the estimation of dutasteride in bulk and pharmaceutical formulations

A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of dutasteride in pharmaceutical formulations and bulk drugs using C-18 column (150 mm × 4.6 mm, 5.0 μm). The mobile phase composed of methanol: phosphate buffer saline (PBS) (80:20, v/v), pH 6.8 adjusted with O-phosphoric acid and the flow rate was maintained at 1ml/min at 30°C temperature. The retention time of dutasteride was found to be 4.1 min. Linearity was established in the range of 1-15 μg/ml with a coefficient correlation of 0.999 and the eluents were monitored at 230 nm. The percentage recoveries were found to be in the range of 99.06-100.60%. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to limit of detection, limit of quantification, precision, accuracy, Linearity and system suitability. This method can be successfully employed for simultaneous quantitative analysis of dutasteride in pharmaceutical formulations and bulk drugs as well.