Stability Indicating UV-Spectrophotometric Method Development and its Validation for the Determination of Imatinib Mesylate in Bulk and Formulation

Abstract

A Simple and precise UV-spectroscopic method was developed for the determination of Imatinib Mesylate in its bulk and formulation. The developed method has been validated for various parameters like specificity, accuracy, linearity, robustness according to USP general chapter<1225> and ICH Q2R1 guidelines. Pure solution of Imatinib Mesylate was scanned in the whole range of UV region where it has shown the maximum absorbance at 258nm. The RSD values for method precision and intermediate precision were found to be well within the acceptance criteria and the series of dilutions were found to be linear (2-12ug/ml) where r2= 0.999 was the regression value. Limit of detection (0.2925μg/ml) and Limit of quantification (0.8977μg/ml) of IMT were established. Further, the drug has been subjected to various stress conditions, and percent degraded was reported. Drug solutions have shown stability on the benchtop for up to 8 hours and 72 hours when the solutions were refrigerated.