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A simple, fast, novel and reproducible analytical method by using High-performance liquid chromatographic (HPLC) /High resolution mass spectrometry was proposed. Quadrupole Time of Flight coupled with Evaporative Light Scattering Detector (ELSD), Photo Diode Array detector and dual Electrospray ionization (dual ESI) multistage tandem mass spectrometry (LC-MS) were used to identify of Gefitinib in tablet dosage form for validated and estimation. Efficient Chromatographic separation of analytes was achieved on Agilent XDB-C18 column (4.6 x 50mm, 1.8um) using an isocratic elution mode with a mobile phase comprised acetonitrile and 0.1% formic acid in water (75:25, v/v). The flow rate was 500 μL/min and effluents were monitored at 250nm.The chromatographic run time was 2 min. The column effluents were detected by Agilent Accurate mass Q-TOF LC/MS 6500 series mass spectrometer using dual electrospray ionization (ESI) in negative mode (445.1299m/z and chlorine adduct 481.1056m/z).The developed LCMS method is validated with respect to linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. The method was observed to be limit-of-detection (LOD) and limit-of-quantification (LOQ) was found to be 5.56ppm and 11.12ppm respectively. The method was successfully used for applied for the qualitative determination of Gefitinib in tablet formulation.
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