Abstract
A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the related substance in Imatinib mesylate with greater precision and accuracy. A SunFireTM C18, (4.6 X 150) mm, using acetonitrile: methanol mobile phase at a flow rate of 1.0 ml/min, and UV detection at 230 nm, was employed. The retention times of Imatinib mesylate, acid impurity and amine Impurity were about 17.96, 1.47 min and about 14.11 min, respectively. The standard curves were linear over the concentration range of 0.25 µg/ml to  3.75 µg/ml. The LOD and LOQ values for acid impurity were 0.01 µg/ml and 0.03 µg/ml, for amine impurity were 0.002 µg/ml and 0.005 µg/ml, and for Imatinib mesylate were 0.01 µg/ml and 0.04 µg/ml respectively. The percentage recovery was found to be 96.2 to 99.9 and the % RSD of intraday and inter day precision was found to be 0.00 and 0.00 respectively. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible and found to be specificity, linearity, and precision, intermediate precision, and accuracy, stability in the RS solution and robustness.
