Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec® capsules

The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of imatinib mesylate and of the impurity product in Glivec® capsules (Novartis, Switzerland). Separations were performed on a X Terra™ 150 mm×4.6 mm, 5 μm particle size column at 25 °C. The mobile phase was a mixture of methanol–water–triethylamine (25:74:1, v/v/v) with flow rate of 1.0 ml min−1. pH value of water–triethylamine (TEA) was adjusted to 2.4 with orthophosphoric acid before adding of methanol. UV detection was performed at 267 nm. Acetaminophen was used as an internal standard. The method was validated statistically for its selectivity, linearity, precision, accuracy and robustness. Due to its speed and accuracy, the method may be used for quality control analyses.