文档介绍：Abstract
This paper describes the development and validation of a new, simple, fast, and sensitive liquid chromatographic method for the determination of imatinib mesylate. Imatinib mesylate is not listed in any pharmacopoeia, and there are few methods in the literature for its quantitation in pharmaceutical dosage forms. In this work, a C18 μBondapak® ( mm, 5 µm) column was used as the stationary phase, and 30 mM sodium heptane sulphonic acid in  M KH2PO4 (pH ):MeOH (42:58) was the mobile phase. Detection was performed on a UV detector at 237 nm. Through the evaluation of the analytical parameters, it was shown that the method is linear (r=) at concentrations ranging from  mg/mL to  mg/mL. The relative standard deviation values [RSD] for intra- and inter-day precision studies were and . Recoveries ranged between and .
Keywords: Imatinib mesylate; HPLC; Assay; Stability-indicating method
Abstract
The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of imatinib mesylate and of the impurity product in Glivec capsules (Novartis, Switzerland). Separations were performed on a X Terra 150 mm x mm, 5 microm particle size column at 25 degrees C. The mobile phase was a mixture of methanol-water-triethylamine (25:74:1, v/v/v) with flow rate of 1.