Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: Validation and application

Kim Keil, Jill Hochreitter, Robin DiFrancesco, Barry S. Zingman, Richard C. Reichman, Margaret A. Fischl, Barbara Gripshover, Gene D. Morse

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Atazanavir (ATV) is a widely used human immunodeficiency virus (HIV)-1 protease inhibitor (PI) that, like other approved PIs, has been considered as a candidate for therapeutic drug monitoring (TDM). To provide ATV assay results that can be applied to patient management through TDM, the assay would need to perform in a manner consistent with Clinical Laboratory Improvement Amendments (CLIA) standards. To quantitate ATV concentrations in human plasma, the authors added ATV to a previously published reversed-phase high-performance liquid chromatography (HPLC) method from their laboratory. Detection was effected with use of a photodiode-array detector (PDA) collecting spectra at 248 nm. This method allows for detection of ATV to a lower limit of quantitation of 0.05 μg/mL, with an intra-assay coefficient of variation (CV%) of 8.9% or less over 5 days of testing and an interassay CV% ranging from 1.4 to 6.4%. The assay has met passing requirements for interlaboratory proficiency testing for 2 years nationally and internationally, with accuracy within ±15% over all test samples. During 2 years, more than 100 batches of analyses have been performed and have proved the method is rugged, specific, and accurate. This assay method is currently used in the authors' clinical research program in TDM.

Original languageEnglish (US)
Pages (from-to)103-109
Number of pages7
JournalTherapeutic Drug Monitoring
Volume29
Issue number1
DOIs
StatePublished - Feb 2007

Keywords

  • Antiretrovirals
  • Atazanavir
  • Liquid chromatography
  • Therapeutic drug monitoring

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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