A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF TUCATINIB IN BULK AND MARKETED FORMULATION BY RP HPLC METHOD

An analytical, specific, accurate, precise, robust, efficient and simple RP-HPLC method has been developed and validated for the determination of Tucatinib in bulk and was applied on marketed Tucatinib products. The mobile phase used for the chromatographic runs consisted of Phosphate Buffer (0.02M) and Acetonitrile in the proportion of 48:52% with maintained at pH-2.80 by diluted OPA solution. The separation was achieved on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 248 nm. The method was linear at the concentration range 30–70 μg/ml for Tucatinib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Tucatinib limit of detection (LOD) and limit of quantification (LOQ) were 0.09μg/ml and 0.27μg/ml respectively. Keywords: Tucatinib, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.