Study on the bioavailability of nateglinide-hydroxypropyl-beta-cyclodextrin complex capsule in rabbits by liquid chromatographic-tandem mass spectrometry

Biomed Chromatogr. 2004 Oct;18(8):532-7. doi: 10.1002/bmc.351.

Abstract

To evaluate the bioavailability of nateglinide-hydroxypropyl-beta-cyclodextrin (HPCD) complex, a rapid and specific liquid chromatographic-tandem mass spectrometric method was developed and validated to determine nateglinide in rabbit serum. The analyte was extracted from serum samples by liquid-liquid extraction, separated on a Zorbax C(18) column and detected by tandem mass spectrometry with an atmospheric pressure chemical ionization interface. Daidzein was used as the internal standard. The method has a lower limit of quantitation of 0.25 mg/L using 200 micro L serum. The intra- and inter-day relative standard deviations calculated from quality control (QC) samples were below 4%. The inter-day relative error was within 1%. Nateglinide serum concentrations in rabbits given nateglinide-hydroxypropyl-beta-cyclodextrin complex were much higher than those given the free drug. Significant difference was observed in main pharmacokinetic parameters of t(max) and C(max) but not AUC(0-t) between the complex and free drug. It was concluded that the absorption rate of nateglinide-HPCD complex was enhanced, compared with that of nateglinide free drug.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Hydroxypropyl-beta-cyclodextrin
  • Animals
  • Biological Availability
  • Capsules
  • Chemistry, Pharmaceutical
  • Chromatography, Liquid / methods*
  • Cyclohexanes / pharmacokinetics*
  • Male
  • Mass Spectrometry / methods*
  • Nateglinide
  • Phenylalanine / analogs & derivatives*
  • Phenylalanine / pharmacokinetics*
  • Quality Control
  • Rabbits
  • Sensitivity and Specificity
  • beta-Cyclodextrins / pharmacokinetics*

Substances

  • Capsules
  • Cyclohexanes
  • beta-Cyclodextrins
  • 2-Hydroxypropyl-beta-cyclodextrin
  • Nateglinide
  • Phenylalanine