Method development and validation of tepotinib in bulk and pharmaceutical dosage form by using RP-HPLC

Background: Tepotinib, a selective MET inhibitor, is an effective targeted therapy for non-small cell lung cancer (NSCLC) patients harboring MET exon 14 skipping mutations. Reliable, validated analytical methods are essential for its quality control, stability evaluation, and regulatory compliance.Aim and Objective: The present study aimed to develop and validate a simple, precise, accurate, and stability-indicating RP-HPLC method for the estimation of Tepotinib in bulk and pharmaceutical dosage forms in accordance with ICH Q2(R1) guidelines.Materials and Methods: Chromatographic separation was achieved on a Kromasil C18 column (150 × 4.6 mm, 3.5 µm) using an isocratic mobile phase of acetonitrile and 0.2% octane sulfonic acid buffer (20:80, v/v, pH 2.5) at a flow rate of 1.0 mL/min. Detection was carried out at 223 nm with a 10 µL injection volume. Method validation parameters including specificity, linearity, accuracy, precision, robustness, sensitivity, and stability-indicating capability were systematically assessed.Results: Tepotinib eluted at 2.076 min with excellent peak symmetry and efficiency (plate count: 13,214; tailing factor: 1.02). The method exhibited outstanding linearity in the range of 25–150 µg/mL (R² = 0.99988). Recovery values ranged from 99.0–100.1%, confirming accuracy, while intra-day and inter-day precision showed %RSD below 1%. Robustness testing demonstrated negligible effects of small variations in flow rate and mobile phase composition. The LOD and LOQ were determined to be 0.50 µg/mL and 1.80 µg/mL, respectively. Forced degradation studies under acidic, alkaline, oxidative, reductive, thermal, photolytic, and hydrolytic conditions confirmed the method’s stability-indicating nature, with degradation ranging from 0.6% to 10.9%.Conclusion: The developed RP-HPLC method is rapid, precise, accurate, robust, and stability-indicating. It is suitable for routine quality control analysis, stability testing, and regulatory applications for Tepotinib in bulk and pharmaceutical dosage forms.