Validation of Finasteride Tablets USP by HPLC Isocratic with UV Detector

    Debasish Mohapatra, Rahul Nayak, Debadash Panigrahi, Surya Narayan Das
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    TLDR The method is effective and suitable for testing finasteride tablets.
    The study aimed to validate an analytical method for evaluating finasteride in bulk drug commercial products using HPLC with UV detection. The method involved eluting finasteride from a Kromasil ODS C18 column with a mobile phase of acetonitrile and ortho phosphoric acid. The analysis showed a retention time of 3.45 minutes and was completed in under 8 minutes. The method was assessed for various parameters such as specificity, precision, and stability, all of which met the acceptance criteria. The method's ruggedness was confirmed through intermediate precision tests. Statistical comparisons using t-test and F-test indicated that the method is sensitive, selective, and suitable for quality control testing, adhering to ICH guidelines.
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