Abstract

METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF IMATINIB MESYLATE TABLET DOSAGE FORM BY RP-HPLC

G. Sai Krishna, Dr. D. Kumar Swamy*, D. Srinivas

ABSTRACT

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Imatinib Mesylate in pure form and pharmaceutical dosage form. Separation of Imatinib Mesylate was successfully achieved on a Develosil ODS HG-5 RP C18, 5m, 15cmx4.6mm column in an isocratic mode utilizing Phosphate buffer: Acetonitrile in the ratio of 60:40 % v/v at a flow rate of 1.0 mL/min and the detection was carried out at 268nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 10-40mcg/mL for Imatinib Mesylate. The correlation coefficient was found to be 0.996 for Imatinib Mesylate. The LOD and LOQ for Imatinib Mesylate were
found to be 0.341μg/mL and 1.023 μg/mL respectively. The proposed method was found to be good percentage recovery for Imatinib Mesylate, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Keywords: Imatinib Mesylate, RP-HPLC, Accuracy and ICH Guidelines.