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- W4310963742 abstract "A new assay was developed to measure the concentration of remimazolam besylate (CNS7056B) and its major carboxylic acid metabolite (CNS7054X) in human plasma. For this new assay method, midazolam-d4 maleate was used as an internal standard. After setting up a previously described assay method, using CNS7056-d4 and CNS7054-d4 as internal standards, analytical results of both methods were compared. For the new analytical method, ultra-high-performance liquid chromatography (UHPLC) with tandem mass spectrometry was applied. A purification method, using solid phase extraction, was developed and validated. The chromatographic separation of the analytes was achieved with a mobile phase gradient using a Water Acquity™ UHPLC-System. The Kinetex™ biphenyl 50 × 2.1 mm UHPLC column was used with a particle diameter of 1.7 μm (Phenomenex, Germany). A measuring range of 0.6-2,000 ng/mL for CNS7056B and of 6-20,000 ng/mL for CNS7054X could be achieved with this new assay. The lower limit of quantification was 0.6 ng/mL for CNS7056B and 6 ng/mL for CNS7054X. The assay was validated according to US Food and Drug Administration guidelines. The new method showed an accuracy of 96.9-110.4% and a precision of 2.1-6.7% for both analytes." @default.
- W4310963742 created "2022-12-21" @default.
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- W4310963742 date "2022-12-06" @default.
- W4310963742 modified "2023-10-12" @default.
- W4310963742 title "Quantification of Remimazolam Besylate (CNS7056B) and Its Metabolite (CNS7054X) by LC–MS/MS in Human Plasma Using Midazolam-d4 Maleate as Internal Standard" @default.
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- W4310963742 doi "https://doi.org/10.1093/chromsci/bmac097" @default.
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