RP-HPLC Technique for Dutasteride Quantitative Estimation in Tablet Dosage Form: Formulation and Validation of Analytical Technique

    January 2024 in “ International Journal of Biological and Environmental Investigations ”
    STEPHEN DORAIRAJI M, M. Rajaram, Ahammed Shakkeela Yusuf Erattil, Seena K.X., Sudhahar Dharmalingam, Rajesh K.S, Ahire Kishori Nilesh, Sumit Kumar, Parminder Kumar
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    TLDR A reliable method was developed to measure dutasteride in tablets accurately and consistently.
    The study developed and validated a reliable RP-HPLC method for quantifying dutasteride in tablet dosage forms, using a Shiseido C18 analytical column and a mobile phase ratio of MeOH:ACN:H₂O (75:10:15 V/V/V) at a UV detection wavelength of 235 nm and a flow rate of 0.7 ml/min. The method showed high sensitivity, accuracy, precision, selectivity, and consistency, with a linear calibration plot in the concentration range of 10-22 ppm, LOQ of 5.3010 µg/ml, and LOD of 10.999 µg/ml. The %RSD was within acceptable limits, confirming the method's reliability for routine quality control and stability testing of dutasteride in pharmaceutical formulations.
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