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

Abstract

RP-HPLC is a novel analytical technique that can be used to detect dutasteride in pharmaceutical formulations and bulk pharmaceuticals. The aim of developing this technique was to provide an analytical RP HPLC method based on the Shiseido C18 analytical column that is accurate, dependable, and analytical for determining the concentration of dutasteride in both bulk and single component forms. The phase of mobile phase MeOH: ACN: H2O ratio was 75:10:15 (V/V/V) at a UV detector wavelength of 274 nm, and the flow rate remained constant at 0.7 ml/min. At 8:34 min, the dutasteride case was concluded amicably. The run lasted 10 min, with the temperature remaining at 20°C. Tests were conducted to ensure that the recently developed analytical RP-HPLC technology satisfies the reliability requirements. In compliance with the ICH Revised Q2 (R1) guidelines for analytical technique validation, it was verified. The analytical technique's method features demonstrated its ability to maintain its sensitivity, accuracy, precision, selectivity, and consistency throughout time. A straight line relationship between the concentration range of 10 to 22 ppm was displayed in the calibration plot. 5.3010 µg/ml was the LOQ, while 10.999 µg/ml was the LOD. The drug's consistency test indicated that the procedure is most likely rather excellent. Reliability tests revealed that the %RSD was within allowable bounds. The authorised technique quantified dutasteride in pharmaceutical formulations and bulk drugs satisfactorily.