Abstract

A NOVEL UV- SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB MESYLATE IN BULK AND TABLET DOSAGE FORM

Suresha D. N.*, Rashmi T. and Pramila T.

ABSTRACT

A novel, simple, accurate and precise Area under curve spectroscopic method was developed and validated for the estimation of Imatinib Mesylate in bulk and Pharmaceutical dosage forms and has an absorption maximum between 230-240 nm in 0.1 M HCl. The Linearity was found to be in the concentration range of 2-16 μg/ml and the correlation coefficient was found to be 0.9998 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.0573 X + 0.0007. The % recovery values were found to be within 99.27 -100.87 % showed that the method was accurate. The LOD and LOQ were found to be 0.0495 and 0.1485 mcg / ml, respectively. The % RSD values were less than 2. The method has been validated according to ICH guidelines for linearity, accuracy, precision, robustness, ruggedness. Limit of detection and limit of quantitation. Proposed method was successfully applied for the quantitative estimation of Imatinib mesylate in bulk and pharmaceutical dosage form.

Keywords: Imatinib mesylate, Area under curve spectroscopy, 0.1M HCl, accuracy.