Simultaneous Estimation of Finasteride and Tamsulosin Hydrochloride in Combined Dosage Forms by RP-HPLC-PDA Method

    January 2012
    M. Sindhura, R. Prashanthi, Buchi N. Nalluri
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    TLDR The method accurately measures Tamsulosin and Finasteride in medication and is suitable for regular quality checks.
    The document from 2012 detailed the development and validation of an RP-HPLC-PDA method for estimating Tamsulosin (TAM) and Finasteride (FIN) in bulk and tablet forms. The method demonstrated good linearity for TAM and FIN within specific concentration ranges and had low limits of detection (0.16µg/mL for TAM and 0.6µg/mL for FIN). The validation process, adhering to ICH guidelines, confirmed the method's precision, accuracy, specificity, robustness, and stability, with recovery rates near 100% for both drugs. The method was sensitive, reproducible, and reliable, with assay results for a commercial combination formulation showing 99.96% for TAM and 99.93% for FIN, aligning with label claims. It was deemed suitable for routine quality control tests and compatible with MS detection.
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