Analytical method development and validation of Alfuzosion and Dutasteride by RPHPLC

The Aim is Development & Validation of Alfuzosin 10Mg & DutaSteride 0.5mg Using Parameters such Precision Accuracy, linearity, specificity, robustness, Ruggedness.

The proposed project success full attempt has been made to develop simple accurate economic & rapid methods for the estimation of tablet formulation & to validate the methods as a result three simple accurate methods were developed & validated.

The System Suitability Parameters Prove that the Proposed method is equally suitable for estimation of ALFU& DUTA the Chromatogram For Sample were found to be Satisfactory on Rp-18(2)250*4.6mm 5µm column using mobile phase combination of buffer Acetonitrile (58;42v/v) with flow rate of 1.0ml/min both the peaks were found to be symmetrical as found from symmetry from of 1.01 for ALFU &DUTA .resolution proposed method satisfactory baseline peak showing separation .Retention time Duta-5min and aifu-2min estimate theoretical plate 5689 per meter recovery of drug acceptance limit 97-103 % .Runtime 8min detector used UV detector 225nm. flow rate 1.0 ml /min the method as found liner over the concentration 20-120mg/ml for ALFU& 1-6mg /ml for DUTA correlation coefficient of0. 998 the method has been validated as per the guideline given by ICH requirements to assure that the method consistently meets the Predetermined Specifications & quality attributes