ABSTRACT
An isocratic reversed-phase liquid chromatography method with UV detection has been developed for the purity evaluation of imatinib mesylate in bulk drug. The method is selective and is capable of detecting all process intermediates and other related compounds, which may be present at trace levels in the drug substance. The method was validated on a Symmetry Shield RP18 analytical column (150 x 4.6 mm, 5 microm), mobile phase consisting of 30 mM sodium octane sulphonic acid in 10 mM aqueous KH2PO4 (pH 2.5 with H3PO4): MeOH in the ratio of 42:58 v/v. The flow rate was set at 1.0 ml/min and the column was maintained at room temperature. The injection volume was set to 10 microl and the detector was set at a wavelength of 237 nm. The method was validated in terms of system precision, method precision, linearity, accuracy, limit of detection and limit of quantification.
