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      A rapid and sensitive UPLC–MS/MS method for determination of remimazolam and its main metabolite in human urine and its application in clinical urine recovery study


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          Remimazolam is a new chemical entity belonging to the benzodiazepine class of sedative drugs. A sensitive and rapid method based on ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) has been developed and validated for the determination of remimazolam and its major carboxylic acid metabolite (M1) in human urine. Urine samples were prepared by dilution and analyzed using an isocratic chromatographic separation. Inter- and intra-batch results for remimazolam were within 10.7% for accuracy and 5.5% for precision, and for M1, within 5.8% for accuracy and 4.2% for precision, respectively. This study represents the first reported example for the quantification of remimazolam and its main metabolite in human urine. Furthermore, this method has been successfully applied for the urine recovery study of remimazolam in Chinese healthy subjects. Only about 0.01% of the administered remimazolam dose was eliminated in the urine over the 24 h period in the form of unchanged remimazolam, and more than 75.1% of the administered dose was eliminated in the form of M1. Remimazolam is excreted mainly in the form of M1 in urine after intravenous administration, and there is no excessive accumulation in vivo after administration of remimazolam.

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          Author and article information

          Acta Chromatographica
          Acta Chromatographica
          Akadémiai Kiadó
          June 2018
          : 30
          : 2
          : 109-113
          [ 1 ]Department of Pharmacy The First Affiliated Hospital of Nanchang University , Nanchang 330006, China
          [ 2 ]Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences , Beijing 100730, China
          Author notes
          © 2017 The Author(s)

          This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercialpurposes, provided the original author and source are credited, a link to the CC License is provided, and changes - if any - are indicated.

          : 16 February 2017
          : 14 March 2017
          Page count
          Pages: 5
          Original Research Paper

          Materials properties,Nanomaterials,Chemistry,Nanotechnology,Analytical chemistry,Thin films & surfaces
          UPLC–MS/MS,Remimazolam,urine recovery study,metabolite,analytical method


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