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Masayuki Furukawa,Kenichi Miyata,Chie Kawasome,Yoshiko Himeda,Kenji Takeuchi,Toshihisa Koga,Yukihiro Hirao,Ken Umehara 대한약학회 2014 Archives of Pharmacal Research Vol.37 No.12
Tolvaptan is a competitive vasopressin V2-receptor antagonist that inhibitswater reabsorption in the renalcollecting ducts. A selective and sensitive liquid chromatography–tandem mass spectrometry method for determiningtolvaptan and its nine metabolites in rat serum was developedand validated. An analogue of tolvaptan was used as aninternal standard. Sample preparation involved protein precipitationfollowing solid-phase extraction. Chromatographicseparation was performed on a C18 reversed-phase columnwith a linear gradient elution. The flow rate was 0.25 mL/min,and total run time was 30 min. The analytes were detected bytandem mass spectrometry using an electrospray ionizationinterface in positive ion mode and multiple reaction monitoring. The calibration curve showed linearity over the concentrationrange from 5 to 1,000 ng/mL for each analyte. Thelower limit of quantification using 0.1 mL of rat serum was5 ng/mL for each analyte. Precision did not exceed 5.7 %, andaccuracy as relative error were within ± 7.5 % for all analytes. The validated method was successfully applied toevaluate the pharmacokinetics of oral tolvaptan in rats, indicatingthe systemic exposure to tolvaptan in females eighttimes larger than that in males.