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A specific and sensitive liquid chromatography–electrospray ionization–tandem mass spectrometric method was developed for the quantification of imatinib and its primary metabolite  N -desmethyl imatinib in human plasma. Protein precipitation with methanol was used for sample preparation. High-performance liquid chromatographic separation was performed on a Thermo BDS Hypersil C18 column (4.6 × 100 mm, 2.4 µm) with methanol–water (55:45, v/v) containing 0.1% formic acid and 0.2% ammonium acetate as the mobile phase, using isocratic elution at a flow rate of 0.7 mL/min. Detection was conducted with positive electrospray ionization multiple reaction monitoring of the ion transitions at  m/z  494 → 394 for imatinib, 480 → 394 for  N -desmethyl imatinib and 297 → 110 for the internal standard (palonosetron). The assay was validated in the concentration ranges of 8–5,000 ng/mL for imatinib and 3–700 ng/mL for  N -desmethyl imatinib. The quantification limits for imatinib and  N -desmethyl imatinib were 8 and 3 ng/mL, respectively. The intra-day and inter-day precision values of the assay (expressed as percentage relative standard deviation) were less than 15% at all concentration levels within the tested range, and the accuracy values were between 85 and 115%. The established method was successfully applied to the pharmacokinetic study of imatinib mesylate capsules in 24 healthy Chinese volunteers.

LC–MS-MS Determination of Imatinib and N -Desmethyl Imatinib in Human Plasma