Dasatinib and Lenvatinib are tyrosine kinase inhibitors widely prescribed for hematological malignancies and solid tumors. Their simultaneous estimation in pharmaceutical dosage forms is critical for quality control, therapeutic safety and regulatory compliance, especially when used in combination regimens. Chromatographic separation was achieved on a Shim-pack C18 column (150 × 4.6 mm, 5 µm) using an isocratic mobile phase of phosphate buffer (0.05 M, pH 3.0) and acetonitrile (35:65, v/v) at a flow rate of 1.0 mL/min. Detection was performed at 265 nm with a 10 µL injection volume. Validation parameters included system suitability, specificity, linearity, accuracy, precision, robustness and sensitivity. Dasatinib and Lenvatinib were eluted at 2.4 and 3.5 minutes, respectively, with sharp and well-resolved peaks. The method demonstrated excellent linearity (R² > 0.9999), recoveries of 99–101% and %RSD < 2%. LODs were 0.082 µg/mL and 1.13 µg/mL, respectively. Assay results of marketed formulations confirmed drug content within 99–101% of label claims. The validated RP-HPLC method is rapid, accurate, precise and robust, making it suitable for routine quality control, stability testing and regulatory applications.
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