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 ”

Yesupadamu Rayinuthala, David Raju Medepalli, A. LAKSHMANARAO

finasteride tadalafil LC-MS/MS pharmacokinetic studies rat plasma Waters Symmetry C18 column perchloric acid acetonitrile Propecia Cialis

Studysummary This study describes a new LC-MS/MS method for analyzing Finasteride and Tadalafil, demonstrating system suitability, linearity, and accuracy in pharmacokinetic studies in rats, aligning with USFDA guidelines.

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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.

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