BIO ANALYTIC AND ANALYTIC METHOD QUANTITATIVE TO TUCATINIB ESTIMATION IN PURE AND PHARMACEUTICAL DOSAGE FORM

Abstract

A simple one, accurate and precise method for estimating tucatinib in tablet dosage form was developed on symmetry C18 column (150x4.6mm, 3.5µ) using buffer and acetonitrile 40:60 pumped through a column with 1ml/min flow rate 0.1 percent formic acid of the buffer used in this method. The run time was 6 min in assay method and 12 min in bio analytical method. Reference standard and sample solutions were prepared by dissolving firstly in acetonitrile and diluted with diluents (mobile phase). Cisplatin was used as internal standard in bio analytical technique. These assay and bio analytical methods establish good linearity results (R2-0.999) with an optimized wavelength of 220nm. The technique was validated in assay method with respect to specificity, linearity, accuracy, robustness, LOD, LOQ, method precision, intermediate precision, degradation and in bio analytical method the technique was validated regarding specificity, linearity, recovery, matrix factor, precision, accuracy, and stability. Keywords: Tucatinib, HPLC, Development, LC-MS/MS, Rat plasma.