Determination of dutasteride by LC: Validation and application of the method

A simple, rapid, and stability-indicating reversed-phase high-performance liquid chromatographic (LC) method for analysis for dutasteride has been successfully developed. Chromatography was performed on a 150 mm x 4.6 mm C(18) column with acetonitrile-water 60:40 (v/v) as isocratic mobile phase at 1.0 mL min(-1). Ultraviolet detection of dutasteride was at 210 nm. Its retention time was approximately 10 min and its peak was symmetrical. Response was a linear function of concentration over the range 0.2-1 mu g mL(-1) (R(2) = 0.997) and the limits of detection and quantitation were was 0.05 and 0.10 mu g mL(-1), respectively. The method was validated for linearity, precision, repeatability, sensitivity, and selectivity. Selectivity was validated by subjecting dutasteride stock solution to photolytic, acidic, basic, oxidative, and thermal degradation. The peaks from the degradation products did not interfere with that from dutasteride. The method was used to quantify dutasteride in pharmaceutical preparations.