Vinay Kumar Nema*, Chaitanya Bangari , Chandaka Madhu, Dr.M.B.Venkatapati Raju
The method development and validation of Dutasteride and tamsulosin hydrochloride was done by RP-HPLC with the mobile phase was Acetonitrile: Phosphate buffer mixed in the ratio of 80:20 % v/ v. A Symmetry C18 (4.6 x 150mm, 5m, Make XTerra) column used as stationary phase. The detection was carried out using UV detector at 274 nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of Dutasteride and tamsulosin hydrochloride were found to be from 25-125 mg/ml. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-102% of dutasteride and tamsulosin hydrochloride LOD and LOQ was found to be within limit. There was a significant degradation in the presence of 0.1N HCl, 0.1N NaOH, 3% H2O2 and also on heat. C18 column guarantees better peak shape, better resolution and lower pressure during operation. So the method is stability indicating. Keywords: Dutasteride , Tamsulosin Hydrochloride, Acetonitrile ,Phosphate buffer, Degradation, Stability.