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April 3, 2026Current Spectroscopy and Chromatography

Bioanalytical Method Development, Validation, and Quantification ofDutasteride in Rat Plasma by Reverse Phase HPLC

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Authors

SPSmita PawarAKAmol KalePKPratik Kapase

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Overview

This analysis develops a reverse-phase HPLC method for measuring dutasteride in rat plasma, suggesting a reliable alternative to complex techniques.

Key Points

  • To develop and validate a reverse-phase HPLC method for quantifying dutasteride in rat plasma for pharmacokinetic studies.
  • Developed a reverse-phase HPLC method according to ICH Q2(R2) guidelines.
  • Processed plasma samples using protein precipitation for extraction.
  • Used a Syncronis C18 column for chromatographic separation with an isocratic mobile phase of methanol and water.
  • Achieved a flow rate of 1 mL/min and eluted dutasteride at 3.191 minutes.
  • Exhibited excellent linearity from 50 to 250 µg/mL with an r² of ≥ 0.9992.
  • Established lower limit of quantification at 6.39 µg/mL.
  • Demonstrated accuracy between 90% and 110% with inter-day precision under 2% RSD.
  • Achieved extraction recovery greater than 90%, confirming method efficiency.

Cite This Study

Pawar et al. (2026) studied this question.

synapsesocial.com/papers/69cf5ede5a333a821460d97fhttps://doi.org/10.2174/0129504910431123260226131354
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