Development of Validated Methods for the Simultaneous Quantification of Finasteride and Tadalafil in Newly Launched FDA-Approved Therapeutic Combination: Greenness Assessment Using AGP, Analytical Eco-Scale, and GAPI Tools

    January 2023 in “ RSC Advances ”
    Ahmed K. Kammoun, Maan T. Khayat, Ahmad J. Almalki, Rasha M. Youssef
    TLDR The study developed accurate, precise, and environmentally friendly methods to measure Finasteride and Tadalafil in a new FDA-approved combination.
    The study developed and validated green analytical methods for the simultaneous quantification of Finasteride (FIN) and Tadalafil (TAD) in the FDA-approved combination capsule Entadfi™ using derivative spectrophotometry and HPLC. Both methods demonstrated high accuracy, precision, linearity, and sensitivity, with correlation coefficients greater than 0.9995. The greenness of the methods was confirmed using AGP, eco-scale, and GAPI tools, indicating their environmental friendliness. The derivative spectrophotometric method was slightly greener due to lower solvent use and waste production. Stability tests showed that FIN and TAD solutions remain stable for at least 3 hours.
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