Analytical Method Development and Validation for the Estimation of Silodosin and Dutasteride in Capsule Dosage Form by RP-HPLC Method

The present article is aimed to develop a new, simple, fast, rapid, accurate, efficient, reproducible, HPLC method for the method development and validation analysis of simultaneous estimation of silodosin and dutasteride capsules RP- HPLC as per ICH guidelines. The analytical method for the method development and validation estimation of silodosin and dutasteride capsules will be developed by RP-HPLC method by optimizing the chromatographic conditions WATERS 2695 separation module.PDA WATERS 2998 detector with the Empower software, Vacuum PR, Vacuum filter, Pump (MERCK), Ultrasonic bath. The developed method was validated based on ICH guidelines to detect and quantitate both silodosin and dutasteride in dosage form with use of HPLC system equipped with PDA detector. The silodosin peak run time is 2.4 min and the dutasteride runtime is 10.9 min, so the 20 min run time was decreased in 14 min run time. The drug silodosin in the concentration range of 20-120 μg/ml and the drug dutasteride in the concentration range of 1.25-7.5 μg/ml, linear regression was not more than 0.999. The linearity range of Silodosin and Dutasteride was found to be HPLC 20-120 μg/ml and 1.25-7.5 μg/ml respectively. The recovery of silodosin and dutasteride capsules was observed in the range of 99.70% to 100.10%. The results show the method was accurate, precise, sensitive, and economic. The HPLC method was more rapid. Method was successfully applied to the pharmaceutical dosage form (Silo Dart capsules).