Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Imatinib Mesylate

Abstract

The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination of Imatinib mesylate in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Imatinib mesylate in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The % recovery values were found to be within the limits, which showed that the method was accurate. The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 2. The developed method was successfully applied for determination of Imatinib mesylate in pharmaceutical dosage form. The results obtained are in good agreement with those obtained by using the standard method.