Development and validation of RP-HPLC method for quantitative determination of imatinib mesylate in bulk drug and pharmaceutical dosage form

The main aim of present work was to develop a simple, precise, rapid and reproducible isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of Imatinib in pure and in tablet dosage form. An isocratic RP-HPLC was performed by utilizing Welchrom C18 column, (250 mm × 4.6 mm i.d., particle size 5 μm) maintained at ambient temperature and mobile phase composed of a mixture of 10 mM Phosphate Buffer (pH3) Acetonitrile (50 : 50 v/v). The flow rate was adjusted 1.0 mL/min and UV detection was performed at 264 nm. The retention time of Imatinib peak was found at 3.053 minutes. The developed method was linear in the range of 210 μg/mL with correlation coefficient of 0.9999. The method was found to be specific and accurate with the overall mean % recovery of 99.85 %. The % RSD of intra and inter-day precision was found to be 0.833 and 0.877 respectively. The % RSD values were below two for intraday and interday precision indicated that the method was highly precise. The developed method was highly sensitive with LOD of 0.105 μg/mL and LOQ of 0.319 μg/mL. Assay content of Imatinib was determined and the mean % found for Imatinib was in good agreement with the label claim. The proposed method was statistically validated for its linearity, precision, accuracy, specificity, Robustness and ruggedness. The optimized methods proved to be specific, robust and accurate and can be used for quality control of Imatinib in bulk drug and pharmaceutical formulations.