Simultaneous Quantification of Dutasteride and Silodosin Using a Stability-Indicating RP-HPLC Approach

    June 2024 in “ International Journal of Pharmaceutical Quality Assurance ”
    Parag A. Pathade, Madhuri Harde, Bhaskar O. Aher, Vinod Bairagi
    TLDR The method accurately and quickly measures silodosin and dutasteride in mixtures.
    A stability-indicating RP-HPLC method was developed to quantify silodosin (SLD) and dutasteride (DTS) in mixtures, validated according to ICH guidelines. Using a Shimadzu Model LC-2030 PLUS HPLC system with a 231 nm detection wavelength and a 10-minute run time, the method employed a 75:25 methanol-water mobile phase with 0.05% OPA at 1 mL/min. The method demonstrated linearity for SLD (8–40 μg/mL) and DTS (0.5–2.5 μg/mL) with R2 values of 0.9998 and 0.9993, respectively. Both drugs showed accuracy and precision within 2% RSD, with mean recoveries between 97.5% and 102%. The method proved to be fast, accurate, sensitive, and precise for routine analysis of SLD and DTS in bulk and pharmaceutical forms, with stability confirmed through degradation trials.
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