RP-HPLC-Based Stability-Indicating Analytical Method for Concurrent Determination of Finasteride and Tadalafil: Development and Validation

January 2025 in “ International Journal of Drug Delivery Technology ”

M. Palanisamy, Venkata Lakshamana Sagar Dantinapalli, Suresh Pandian Elumalai, M.A. Syed

finasteride tadalafil RP-HPLC stability-indicating method forced degradation studies acidic conditions oxidative conditions alkali conditions reduction conditions thermal conditions hydrolytic conditions Propecia Cialis ENTADFI

TLDR A reliable method was developed to measure Finasteride and Tadalafil together, showing they degrade under certain conditions.

A stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Finasteride and Tadalafil, demonstrating effective separation and high precision with a linearity range of 12.5–75 µg/mL and R² > 0.999. The method showed excellent precision (%RSD < 2%) and sensitivity with LOD/LOQ values of 0.60 µg/mL and 2.00 µg/mL. Assay results for the marketed formulation ENTADFI were 100.0% for Finasteride and 100.2% for Tadalafil. Forced degradation studies revealed that both drugs are susceptible to degradation under various stress conditions, with Finasteride showing maximum degradation under acidic (14.0%) and oxidative (14.7%) conditions, and Tadalafil under alkali (10.8%) and reduction (14.6%) conditions, while minimal degradation occurred under thermal and hydrolytic conditions.

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