The STUDIA UNIVERSITATIS BABEŞ-BOLYAI issue article summary

The summary of the selected article appears at the bottom of the page. In order to get back to the contents of the issue this article belongs to you have to access the link from the title. In order to see all the articles of the archive which have as author/co-author one of the authors mentioned below, you have to access the link from the author's name.

  
       
         
    STUDIA CHEMIA - Issue no. 2,%20Tom%20I / 2019  
         
  Article:   VALIDATED LC-MS/MS METHOD FOR THE DETERMINATION OF THE MUSCARINIC RECEPTOR ANTAGONIST (MRA) SOLIFENACIN FROM HUMAN PLASMA.

Authors:  RÓBERT TŐTŐS, JÓZSEF BALÁZSI. 		 
       
         
  Abstract:  The purpose of this study was the development and validation of an LC-MS/MS method, for the determination of solifenacin from human plasma. The sample workup involved a simple protein precipitation procedure. A core/shell type analytical column (50×2,1 mm, 2.6 Å) was used with C18 stationary phase. The mobile phase consisting of 65% acetonitril and 35% water provided good peak shape, accuracy and precision. The mass spectrometer was operated in positive electrospray ionization mode for analyte and internal standard. The following parameters were evaluated for validation purpose: Selectivity, sensitivity, matrix effect, anticoagulant effect, linearity, precision and accuracy, recovery, short and long term analyte/IS stability in solvent/matrix and carryover. The validated calibration range was 0.71-71.28 ng/ml. The correlation coefficient R2 was at least 0.99 in all validation batches. The validated method has been successfully used for the evaluation of bioequivalence of generic solifenacin 10 mg formulations.

Keywords: solifenacin, muscarinic antagonist, method validation, bioequivalence trial, LC-MS/MS 		 
         
     
         
         
      Back to previous page