Валидация методики количественного определения золпидема в цельной крови методом газовой хроматомасс-спектрометрии

2015 
A method for the quantitative determination of zolpidem in whole blood by GC/MS has been developed and validated. Imipramine hydrochloride is used as the internal standard. The multiple regression coefficient for the obtained calibration straight line is r – 0.999. The proposed technique is metrologically assessed with respect to eight statistical parameters. The efficiency of zolpidem extraction from the model blood at three levels of concentration has been determined. The recovery of target substance was achieved within 96 – 99%. The technique is assessed with respect to specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity, analytical area, correctness, and precision (repeatability and intralaboratory precision). The obtained results are within acceptable limits for statistical processing. The LOD of zolpidem in whole blood is 24.0 ng/mL and the LOQ is 72.7 ng/mL.
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