Development and validation of a stability indicating RP-LC method for determination of imatinib mesylate

作者：Bende Girish; Kollipara Sivacharan; Kolachina Venugopal; Saham Ranendra^*

来源：Chromatographia, 2007, 66(11-12): 859-866.

DOI：10.1365/s10337-007-0415-3

• column liquid chromatography
• microwave-assisted degradation
• orthogonal separation
• imatinib mesylate

A new, sensitive and stability indicating liquid chromatographic method has been developed for the determination of imatinib mesylate (IM). Efficient chromatographic separation was achieved using a C-18 column with simple mobile phase combination delivered in an isocratic mode and quantitation was carried out using ultraviolet detection. For the first time, a novel microwave assisted degradation procedure was employed for stress testing studies. In addition, orthogonal separation technique was applied to demonstrate selectivity of the proposed method. The method has demonstrated excellent linearity over the range of 25-1,600 ng mL(-1). Moreover, the method was found to be sensitive with a low limit of detection (3.35 ng mL(-1)) and limit of quantitation (10.16 ng mL(-1)). The method has shown good and consistent recoveries (99.35-100.69%) with low intra- and inter-day relative standard deviation (RSD) (< 2.5%). Experimental design confirmed that peak area was unaffected by small changes in critical factors, in robustness study. The validated method was successfully applied for determination of IM in pharmaceutical formulations.

• 出版日期2007-12