Abstract

A NEW RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DUTASTERIDE AND TAMSULOSIN IN TABLET DOSAGE FORMS

K. Sujatha*, J.V.L.N. Seshagiri Rao

Abstract

An accurate, precise and reproducible high performance liquid chromatographic method was developed for quantitative estimation of dutasteride and tamsulosin simultaneously in tablet dosage forms. Separation of the drugs was achieved within 10 min on a Hypersil BDS C18, (250 x 4.6 mm, 5) column by gradient elution using mixtures of 0.02M phosphate buffer and acetonitrile (30:70v/v) as the mobile phase at a flow rate of 1.0 mL/min. The analytes in the eluate were monitored at 210 nm. Under the optimized conditions, the retention times obtained for dutasteride and tamsulosin were 3.142 min and 7.045 min respectively.The linearity of quantification was observed in the concentration range of 2.5-15 μg/mL for dutasteride and 2-12 μg/mL for tamsulosin. The performance of the method was validated according to ICH guidelines. The method was found to be suitable for accurate determination of these drugs in tablet dosage forms without any interference from normal excipients.

Keywords: Dutasteride, Tamsulosin, Determination, HPLC, Gradient elution.