Development and Validation of a Robust Stability-Indicating RP-HPLC Method for Quantitative Analysis of Tepotinib in Pharmaceutical Formulations

Abstract

A highly accurate and reliable Reverse Phase -High Performance Liquid Chromatography technique was designed and validated for the quantitative analysis of Tepotinib in drug products. Separation was achieved on a Luna® C18 column (3 μm, 150 mm × 5 mm I.D.) using an isocratic mobile phase consisting of 80% phosphate buffer (0.01 N K₂HPO₄, adjusted to pH 3.5) and 20% acetonitrile at a flow rate of 1.0 mL/min. Detection took place at 270 nm, and Tepotinib was observed at a retention time of 2.235 mins. The method met ICH validation standards, demonstrating selectivity, excellent linearity over the range of 10–50 µg/mL (correlation coefficient R² > 0.999), and accuracy (recovery between 99.26–101.7%). Precision was confirmed, with intra-day and inter-day relative standard deviations of 0.92% and 0.86%, respectively. Test recovery underscored the method’s accuracy, and deliberate adjustments to parameters like temperature, flow, and mobile phase composition established its robustness. This protocol is well-suited for quality control and stability testing of Tepotinib formulations.