DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TAMULOSIN AND DUTASTERIDE IN A BULK AND TABLET DOSAGE FORM

Chromatography is a separation process that is achieved by distributing the substances to be separated between a moving phase and a stationary phase. HPLC is high resolution, high pressure and high-speed liquid chromatography. It has several resolving powers than open column liquid chromatography hence it is used for speedy resolution of complex mixture, separation and determination of species in a variety of organic, inorganic and biological materials. The developed HPLC method was validated for various parameters like accuracy, precision, specificity, LOD, LOQ, linearity, range and robustness as per ICH guidelines. The results obtained were well within the acceptance criteria for all the parameters. The proposed method was applied for simultaneous estimation of Tamsulosin and Dutasteride formulation. The HPLC system used was WATERS Alliance series System with Rheodyne injector 20 μL and the column Inertsil ODS 250 x 4.6 mm, 5 μm. The mobile phase comprised of Sodium phosphate buffer and Acetonitrile in the ratio of 30:70 v/v and flow rate of 1.0 ml/min with UV detection at 233 nm produced peaks of Tamsulosin and Dutasteride in the chromatogram which were well resolved with retention time of 2.939 min and 5.572 min respectively.