Method Development and Validation of Finasteride and Dutasteride in Pharmaceutical Dosage Forms by RP-HPLC Method
Year: 2026
Type: article
Abstract: A simple, rapid, accurate, precise, and economical RP-HPLC method was developed and validated for the simultaneous estimation of Finasteride (FINA) and Dutasteride (DUTA) in pharmaceutical dosage forms. Chromatographic separation was achieved using a Shim-pack C8 column with acetonitrile: water (80:20, v/v) as the mobile phase at a flow rate of 1.0 mL/min and UV detection at 210 nm. The method showed good linearity over 20–100 μg/mL for both drugs, with R² of 0.999. Accuracy was confirmed by recovery studies, with recoveries of 99.32–100.83% for FINA and 100.50–100.76% for DUTA. Precision showed %RSD below 2%. The method was also validated for LOD, and LOQ according to ICH guidelines and was suitable for routine analysis.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: hybrid
OpenAlex ID: W7214528510