Bio-Analytical Method Development and Validation of Finasteride, Tadalafil, and Its Application to Pharmacokinetic Studies in Rat Plasma by Using LC-MS/MS
September 2024
in “
International Journal of Applied Pharmaceutics
”
TLDR A reliable method was developed to measure Finasteride and Tadalafil in rat blood.
The study developed a precise and reproducible LC-MS/MS method for analyzing Finasteride and Tadalafil in rat plasma, using Avanafil as an internal standard. The method demonstrated linear calibration curves for both drugs within the range of 12.5-100 ng/ml. Accuracy and precision recovery results for Finasteride and Tadalafil were above 95% at various quality control levels. The method adhered to USFDA guidelines and was successfully applied to pharmacokinetic studies in rats, confirming its suitability, specificity, linearity, and accuracy.