[Determination of Plasma Concentrations of Imatinib by a Novel Automated Analyzer Based on High-Performance Liquid Chromatography].

LM1010 HPLC is an emerging automated method designed for use in clinical settings. The aim of this study was to compare the analytical performance of LM1010 with the performance of traditional HPLC and LC-MS/MS in the measurement of plasma concentrations of imatinib. Seventy-eight plasma samples from 20 patients (14 men and 6 women) were collected. Plasma concentrations of imatinib in samples from the same patient were analyzed simultaneously using LM1010, HPLC and LC-MS/MS (LSI Medience Corporation). Strong correlations were seen in pairwise comparisons of results from the LM1010 and HPLC methods, the LM1010 and LC-MS/MS methods, and the LC-MS/MS and HPLC methods (Spearman's r=0.936, 0.906, and 0.953, respectively); however, the results from the LC-MS/MS method showed a positive proportional bias in comparison with the results from the LM1010 and HPLC methods, according to Deming analyses (slope=1.064 and 1.105, respectively). In Bland-Altman analyses, the LC-MS/MS method showed a positive mean bias of 98.6 and 112 ng/mL in comparison with the LM1010 and HPLC methods, respectively. Notably, results obtained using the LM1010 method were comparable to those using the HPLC method (positive mean bias=13.6 ng/mL; 95% confidence interval, -7.9-35.1 ng/mL). Biochemical parameters or drugs taken concomitantly with imatinib were not found to affect the bias of the LM1010 method. The LM1010 method can be applied to routine therapeutic drug monitoring of imatinib.