Validated RP-TLC Method with Densitometry for Assay of Finasteride in Simple Pharmaceutical Dosage Form

    April 2018 in “ Current Pharmaceutical Analysis
    Małgorzata Dołowy, Agata Piontek, Alina Pyka-Pająk
    TLDR A new, simple, and accurate method was created to measure finasteride in tablets.
    The study developed and validated a rapid, simple, and cost-effective RP-TLC method combined with densitometry for quantifying finasteride in tablet dosage forms. Chromatographic analysis was performed using silica gel plates and a 1,4-dioxane-water mobile phase, with densitometric scanning at 212 nm. The method showed high accuracy and precision, with a coefficient of variation less than 2%, and was linear over the range of 1.00-4.00 µg/spot with a correlation coefficient of 0.9981. The limits of detection and quantification were 0.24 and 0.74 µg/spot, respectively. The assay results for finasteride in marketed tablets were consistent with label claims and pharmacopoeial standards, indicating the method's suitability for routine analysis.
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