“Bio-Analytical Method Development and Validation for The Estimation of Tamoxifen in Plasma by Using RP-HPLCMethod”

Abstract

A robust and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantification of Tamoxifen in plasma. Tamoxifen, a selective estrogen receptor modulator, is widely used in the treatment of hormone receptor-positive breast cancer, necessitating accurate bioanalytical techniques for therapeutic monitoring and pharmacokinetic studies. The method employed an Agilent C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of methanol and 0.1% acetic acid in water (30:70, v/v), at a flow rate of 0.8 mL/min. Detection was carried out at 236 nm using a UV detector, with a retention time of 5.657 minutes and theoretical plates of 4970, ensuring high resolution. The method demonstrated excellent linearity (R² = 0.999) within a concentration range of 2–10 µg/mL, with precise recovery (98–102%) and reproducibility (RSD < 2%). Validation parameters complied with International Council for Harmonisation (ICH) guidelines, confirming specificity, sensitivity, and robustness. Application to a marketed formulation yielded accurate results, with the method proving suitable for routine clinical and pharmaceutical applications. The validated RP-HPLC method also offers potential for therapeutic drug monitoring and drug-drug interaction studies, supporting optimized breast cancer treatment strategies.