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Development and validation of a selective and sensitive LC-MS/MS method for determination of misoprostol acid in human plasma: Application to bioequivalence study

  • Park, Yong Sun (Drug Development Supporting Service Division, Bio-Medieng Co. Ltd.) ;
  • Kim, Keun Nam (Unimed Pharm. Inc.) ;
  • Kim, Ye Na (Drug Development Supporting Service Division, Bio-Medieng Co. Ltd.) ;
  • Kim, Jung Hwan (Unimed Pharm. Inc.) ;
  • Kim, Jin Young (Drug Development Supporting Service Division, Bio-Medieng Co. Ltd.) ;
  • Sim, Soo Ji (Drug Development Supporting Service Division, Bio-Medieng Co. Ltd.) ;
  • Lee, Heon Soo (Drug Development Supporting Service Division, Bio-Medieng Co. Ltd.)
  • Received : 2014.11.21
  • Accepted : 2015.01.12
  • Published : 2015.02.25

Abstract

A rapid, sensitive and specific method was developed and validated using electrospray ionization (ESI) tandem mass spectrometry (LC-MS/MS) for determination of misoprostol acid in human plasma. Misoprostol $acid-d_5$ was used as in internal standard (IS). The analyte and IS were extracted by simple one step solid phase extraction (SPE). Linearity in plasma was obtained over the concentration range 10~3000 pg/mL and lower limit of quantification (LLOQ) was identifiable and reproducible at 10 pg/mL. The intra- and inter-day precision values were below 9% and the accuracy was ranged from 93.81% to 102.02% at all four quality control samples. The method was has been successfully applied for routine assay to support pharmacokinetic study of misoprostol acid in human plasma after an oral administration of 0.4 mg misoprostol.

Keywords

misoprostol acid;alsoben;human plasma;LC-MS/MS;pharmacokinetics

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