DEVELOPMENT OF RP-HPLC METHOD FOR THE ANALYSIS OF IMATINIB MESYLATE USING PDA DETECTOR AND ITS APPLICATION IN THE EVALUATION OF MARKETED PREPARATION

A simple, sensitive, isocratic and reproducible reversed phase High Performance Liquid Chromatographic (RP-HPLC) method was developed for the estimation of imatinib mesylate using PDA detector. The system consisted of RP-C18 column and the detection was performed at 260 nm. The mobile phase consist of (4ml tetrabutyl ammonium hydroxide and .01M ammonium dihydrogen orthophosphate (pH adjusted to 3 with orthophosphoric acid) and acetonitrile in ratio 60:40) pumped at room temperature and a flow rate of 1ml/min. Imatinib mesylate was eluted at 2.812min. The mean absolute recoveries of Imatinib mesylate was about 100.1% to 100.3% and the limit of detection (LOD) of imatinib was 10 μg/ml and the limit of quanitation (LOQ) is 20 μg/ml. the method shows good linearity in the range 20 μg/ml to 120 μg/ml (r2>0.995). The intra (n=6) and inter (n=6) day assay variations in the linear range is < 4 .Three marketed products containing imatinib mesylate are analyzed to test the applicability of the new method. The percentage of Imatinib mesylate in marketed preparations studied was found to be 99.58%, 99.92 and 100.85 respective to the label claimed.