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| Formato: | Recurso digital |
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Zenodo
2026
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| Acceso en línea: | https://doi.org/10.5281/zenodo.19893387 |
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- <div> <h2><em><span>Background:</span></em><em><span> </span></em><em><span>A<span> </span>simple, rapid, precise, sensitive, and reproducible analytical method was developed for the <span>quantitative estimation</span><span> </span><span>of</span><span> </span><span>Tamsulosin Hydrochloride and Dutasteride in pharmaceutical</span><span> </span><span>dosage </span>forms using Reverse Phase High Performance Liquid Chromatography (RP-HPLC).</span></em></h2> <h2><em><span>Method:</span></em><em><span> </span></em><em><span>Chromatographic<span> </span>separation<span> </span>of<span> </span>Tamsulosin<span> </span>HCl<span> </span>and<span> </span>Dutasteride<span> </span>was<span> </span>achieved<span> </span>using<span> </span>a<span> </span>Waters Alliance e2695 HPLC system equipped with a Luna Phenyl Hexyl column (250 × 4.6 mm, 5 µm).<span> </span>The<span> </span>mobile<span> </span>phase<span> </span>consisted<span> </span>of<span> </span>Acetonitrile<span> </span>and<span> </span>0.1%<span> </span>TEA<span> </span>(pH<span> </span>2.5<span> </span>adjusted<span> </span>with<span> </span>OPA)<span> </span>in the ratio of 20:80 % v/v. The flow rate was maintained at 1.0 mL/min, and detection was performed at 257 nm using a photodiode array (PDA) detector under ambient temperature <span>conditions.</span></span></em></h2> <h2><em><span>Results:</span></em><em><span> </span></em><em><span>The chromatographic method showed good separation with acceptable system suitability parameters. The number of theoretical plates for both drugs was not less than 2000, and the tailing<span> </span>factor<span> </span>was<span> </span>less<span> </span>than<span> </span>2,<span> </span>indicating<span> </span>efficient<span> </span>column<span> </span>performance.<span> </span>The<span> </span>percentage<span> </span>relative standard<span> </span>deviation<span> </span>(%RSD)<span> </span>of<span> </span>peak<span> </span>areas<span> </span>was<span> </span>found<span> </span>to<span> </span>be<span> </span>less<span> </span>than<span> </span>2.0%,<span> </span>demonstrating<span> </span>good precision and repeatability of the method.<span>Validation: </span>The developed method was validated according to the guidelines of<span> </span>the International Council for<span> </span>Harmonisation<span> </span>of<span> </span>Technical<span> </span>Requirements<span> </span>for<span> </span>Pharmaceuticals<span> </span>for<span> </span>Human<span> </span>Use<span> </span>(ICH).<span> </span>The validation parameters such as accuracy, precision, specificity, linearity, and robustness confirmed that the method is reliable and suitable for quantitative analysis.</span></em></h2> <h2><em><span>Conclusion:</span></em><em><span> </span></em><em><span>The developed RP-HPLC method was found to be simple, economical, accurate, precise, and robust. Therefore, the method can be effectively used for routine quantitative analysis and stability<span> </span>studies<span> </span>of<span> </span>Tamsulosin<span> </span>Hydrochloride<span> </span>and<span> </span>Dutasteride<span> </span>in<span> </span>pharmaceutical<span> </span>dosage<span> </span>forms.</span></em></h2> <h2><em><span>Keywords:</span></em><em><span> </span></em><em><span>RP-HPLC,<span> </span>Tamsulosin<span> </span>HCl,<span> </span>Dutasteride,<span> </span>Method<span> </span>validation,<span> </span>Stability<span> </span>indicating<span> method.</span></span></em></h2> </div>