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
”
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Studysummary This study developed and validated a reliable RP-HPLC method for accurately quantifying dutasteride in pharmaceutical formulations and bulk pharmaceuticals using a Shiseido C18 analytical column, demonstrating precision, accuracy, and sensitivity across a concentration range of 10 to 22 ppm.
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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.
