BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FINASTERIDE, TADALAFIL AND ITS APPLICATION TO PHARMACOKINETIC STUDIES IN RAT PLASMA BY USING LC-MS/MS

YESUPADAMU RAYINUTHALA; DAVID RAJU MEDEPALLI; A. LAKSHMANARAO

doi:10.22159/ijap.2024v16i5.50858

Authors

YESUPADAMU RAYINUTHALA Department of Chemistry, Government Degree College, Chebrole, Guntur District, AP-522212, India
DAVID RAJU MEDEPALLI Department of Chemistry, P B Siddhartha College of Arts and Science, Mogalraj Puram, Vijayawada, AP, India
A. LAKSHMANARAO Department of Chemistry, Sri ABR Government Degree College, Repalle, Bapatla District, AP-522265, India

DOI:

https://doi.org/10.22159/ijap.2024v16i5.50858

Keywords:

Finasteride, Tadalafil, LC-MS/MS, USFDA guidelines, Rat plasma

Abstract

Objective: An easy, quick, precise, active and reproducible LC-MS/MS (Liquid Chromatography Tandem Mass Spectrometry) technique was developed for the bio analytical method of Finasteride and Tadalafil using Avanafil as internal standard (IS).

Methods: This article summarizes the recent progress on bioanalytical Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) methods using waters Symmetry C₁₈ column (150x4.6 mm, 3.5µ) column and mobile phase of 0.1% Perchloric acid and Acetonitrile (ACN) in 60:40.

Results: The calibration curve was linear in the range of 12.5-100 ng/ml for Finasteride and 12.5-100 ng/ml Tadalafil. The recovery results of Accuracy and Precision of Finasteride and Tadalafil were 95.10, 96.85, 98.76, 98.81% and 95.77, 97.46, 97.99, 97.01% at different QC (Quality Control) concentration levels. Matrix effect results were within the acceptable limit. An electro spray ionization source was used to study of Finasteride and Tadalafil at m/z 373.5497 → 142.0085, m/z 390.4047→128.1138 for Finasteride and Tadalafil, m/z 484.9516→104.5326 for Avanafil were ion pairs of mass analysis.

Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with USFDA (United States of Food and Drug Administration) guidelines and applied effectively for the investigation of pharmacokinetic studies in rat.

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