A method for the determination of olanzapine concentration in plasma by high performance liquid chromatography tandem mass spectrometry
A technology of high performance liquid chromatography and tandem mass spectrometry, which is applied in the field of determination of olanzapine concentration in plasma by high performance liquid chromatography and tandem mass spectrometry, can solve the problems of not meeting the requirements of detection limit, quality control and sample processing efficiency, reducing the efficiency of biological samples, Large sample volume and other issues, to achieve the effect of eliminating carryover effects, appropriate retention time, and good specificity
Active Publication Date: 2021-06-08
BEIJING CHAOYANG HOSPITAL CAPITAL MEDICAL UNIV
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Problems solved by technology
At present, the LC-MS / MS method reported in the literature to determine the concentration of olanzapine in biological matrices is mainly used in the field of therapeutic drug monitoring (TDM), and has a wide linear range (such as 5-500nM, 0.25-50ng / mL, 1-300ng / mL), and cannot meet the requirements of clinical trials for biological sample detection limit, quality control and sample processing efficiency
In addition, the published methods also have problems such as large sample volume (0.2-0.5mL / sample), long analysis time per sample (6-11min), high lower limit of quantitation (such as 1-5 ng / mL), pre-sample Processing using time-consuming liquid-liquid extraction and solid-phase extraction
Although there are also reports in the literature that some LC-MS / MS methods use protein precipitation, however, these protein precipitation processes still require operations such as drying and reconstitution, which significantly reduces the efficiency of biological sample pretreatment, and has great impact on clinical pharmacokinetics / biology. High-throughput processing of large numbers of plasma / serum samples in equivalence studies presents challenges
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example 1
[0033] 1 solution preparation
[0034] The volumes and weights used to prepare solutions can be adjusted proportionally, and all solutions are stored at room temperature unless otherwise stated.
[0035] 1.1 Preparation of mobile phase solution
[0036] Organic phase (A1): The organic phase used in the experiment was chromatographically pure methanol, which was fixed to volume with a 1L volumetric flask, filtered through a G6 vertical fused glass funnel with a 0.22 μm organic filter membrane, placed in a mobile phase bottle, and ultrasonically degassed. Ready to use after labeling.
[0037]Water phase (B1): Use a graduated cylinder to measure an appropriate amount of pure water and put it in a beaker, add 10mL of 1M ammonium formate solution and 50μL of heptafluorobutyric acid, mix well, place in a volumetric flask and set the volume to 1L, and prepare a solution containing 10mM formic acid The aqueous phase of ammonium and 0.005% heptafluorobutyric acid was filtered through...
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The invention discloses a method for measuring the concentration of olanzapine in plasma by high-performance liquid chromatography tandem mass spectrometry, which comprises: dissolving olanzapine in methanol to prepare standard curve working solutions with multiple concentrations, and dissolving stable isotope internal standards in methanol to prepare Internal standard working solution; add 0‑5μL standard curve working solution of multiple concentrations to blank plasma to make up to 100μL, vortex to make standard curve plasma samples with multiple concentrations, add internal standard working solution, centrifuge, take The supernatant was subjected to quantitative analysis by LC-MS / MS, and a standard curve was drawn; 100 μL of the plasma to be tested was precisely drawn, and the internal standard working solution was added, centrifuged, and the supernatant was taken for quantitative analysis by LC-MS / MS. The concentration of olanzapine was read on the standard curve. The invention has the characteristics of simple and convenient sample pretreatment, short analysis time, less required sample volume, high sensitivity, high recovery rate, small matrix effect and the like.
Description
technical field [0001] The present invention relates to methods for detecting drug concentrations. More specifically, the present invention relates to a method for determining the concentration of olanzapine in plasma by high performance liquid chromatography tandem mass spectrometry. Background technique [0002] Olanzapine (Olanzapine) is an atypical antipsychotic drug developed and marketed by Eli Lilly Pharmaceutical Company of the United States in 1996. The chemical name is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine , the molecular formula is C17H20N4S, and the molecular weight is 456.32. Olanzapine is a second-generation antipsychotic drug that acts on multiple receptor systems, such as 5-HT receptors and histamine receptors. Olanzapine is mainly metabolized by hepatic cytochrome P450 enzymes (such as CYP4501A2) and glutamic acid transferase. [0003] For the quantitative determination of small molecular compounds, high-performance li...
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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8822
Inventor 杜萍刘丽宏李鹏飞
Owner BEIJING CHAOYANG HOSPITAL CAPITAL MEDICAL UNIV