Analytical method development and validation of Alfuzosion and Dutasteride by RPHPLC

YAPPAN, SOLAI JAYALAKSHMI SOLAI and RAJ, J. JUSTIN JEYA (2025) Analytical method development and validation of Alfuzosion and Dutasteride by RPHPLC. World Journal of Biology Pharmacy and Health Sciences, 22 (1). 055-062. ISSN 2582-5542

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