QBD Driven Bioanalytical Method Development and Validation of Tepotinib using RP-UPLC

The research aims to establish a new UPLC method for estimating Tepotinib in human plasma.A simple, precise, and accurate RP-UPLC technique has been developed to quantify Tepotinib (TEP) in human plasma by employing a Quality by Design (QbD) approach.The effective separation of TEP was accomplished using the ACQUITY UPLC HSS C18 Column (1.8 m, 2.1 mm100 mm) and 0.01N Ammonium formate : Methanol in 70:30 v/v delivered at a flow rate of 0.3ml/min.The eluted TEP and internal standard Linagliptin (LIN) were detected at 258nm wavelength with good resolution.A temperature of 30 0 C is maintained in the column throughout the experimental study.Equal volumes of methanol and water are considered as diluent to prepare the standard stock, working standard, and quality control sample solutions.TEP and LIN were eluted at 2.023 min, and 1.668 min, respectively, achieving a resolution of 4.3.The standard curve was linear (r 2 =0.999) across the 8-320 ng/ml concentration range of TEP.The validated method exhibited satisfactory performance aligning with ICH guidelines.The robustness and suitability of the method were further authenticated through QbD studies, making it compatible with therapeutic drug monitoring and determining the pharmacokinetic profile of TEP in In-Vivo studies.