Introduction: Dutasteride, a 5α-reductase inhibitor, is widely prescribed for the treatment of benign prostatic hyperplasia. Although most analytical studies on dutasteride have utilized LCMS/MS techniques, there’s a timely need for a simple, accurate, and reliable alternative method. The objective of this study was to develop and validate a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of dutasteride in rat plasma, intended for pharmacokinetic and bioavailability studies. Methods: A robust RP-HPLC method was developed and validated in accordance with ICH Q2(R2) guidelines. Plasma samples were processed using protein precipitation for extraction. Chromatographic separation was achieved on a Syncronis C18 column (250 mm × 4.6 mm, 5 µm), employing an isocratic mobile phase of methanol and water (80:20, v/v) at a flow rate of 1 mL/min. Dutasteride was eluted at a retention time of 3.191 minutes with a total run time of 6 minutes. Results: The method exhibited excellent linearity in the concentration range of 50–250 µg/mL, with a correlation coefficient (r²) of ≥ 0.9992. The lower limit of quantification (LOQ) was determined to be 6.39 µg/mL. Accuracy ranged between 90% and 110%, while inter-day precision was less than 2% relative standard deviation (RSD). The extraction recovery of dutasteride was greater than 90%, confirming method efficiency and robustness. Discussion: The validated method demonstrated high sensitivity, precision, and reproducibility, meeting all standard bioanalytical method validation requirements. Compared to LC-MS/MS, the RP-HPLC method offers a simpler, cost-effective, and efficient alternative for the routine quantification of dutasteride in plasma samples. Conclusion: A validated, efficient, and sensitive RP-HPLC method was successfully developed for the determination of dutasteride in rat plasma. The method is suitable for routine bioanalytical applications, including pharmacokinetic and bioavailability studies.
Pawar et al. (Mon,) studied this question.