Abstract

METHOD DEVELOPMENT AND VALIDATION OF IMATINIB MESYLATE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

P. Sandhya*, P.Vishnu Priya, Shyamala, N. Anjali Devi, JVC. Sharma

ABSTRACT

The present research work describes a rapid and accurate RP-HPLC for estimation and validation of Imatinib mesylate in tablet dosage form. It is used in the treatment of chronic myeloid leukemia. The separation of drug was achieved by on Phenomenex column (4.6 mm X 150 mm i.d) 5μ column. The mobile phase consists mixture Orthophosphoric buffer (pH 2.5): Methanol (50:50). The detection was carried out at a wavelength 263nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy, precision, robustness and stability of sample solution. The linear ranges for Imatinib mesylate were 10-50 μg/mL, 0.072-2.4 μg/mL respectively with good recoveries i.e., 100.5%.

Keywords: Imatinib mesylate, RP-HPLC, Orthophosphoric acid, Methanol.