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Simultaneous Determination of Unlabeled and Deuterium-Labeled Indinavir in Human Plasma by High-Performance Liquid Chromatography with Tandem Mass Spectrometric Detection

Journal of Pharmaceutical Sciences, ISSN: 0022-3549, Vol: 86, Issue: 2, Page: 193-198
1997
  • 36
    Citations
  • 0
    Usage
  • 6
    Captures
  • 0
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    36
    • Citation Indexes
      36
  • Captures
    6

Article Description

A method for the simultaneous determination of indinavir and its hexadeuterated analog (d 6 -indinavir) in human plasma is described. Isolation of the analytes and internal standard from plasma was achieved via liquid-liquid extraction with methyl- t -butyl ether. The analytes were chromatographed under reversed-phase conditions on a BDS-Hypersil C8 column. A Sciex API III+ tandem mass spectrometer equipped with a turbo ion-spray interface was used as the detector. Multiple reaction monitoring using the parent→product ion combinations of m/z 614→465, 620→471 and 654→505 were used to quantify indinavir, d 6 -indinavir, and internal standard, respectively. The method was validated, using 1-mL aliquots of plasma, in the concentration range in plasma of 1 to 200 ng/mL. Precision of the assay, as measured by the coefficient of variation, ranged from 0.9 to 4.3% and 0.9 to 6.2% for indinavir and d 6 -indinavir, respectively. Indinavir assay accuracy ranged from 95.8 to 105.0% of nominal, whereas the accuracy of the assay for d 6 -indinavir ranged from 97.4 to 104.0% of nominal. The assay was used to support a clinical study in which the stable isotope technique was used to determine the bioavailability of indinavir.

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