TY - JOUR
T1 - Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors
T2 - Validation and application
AU - Keil, Kim
AU - Hochreitter, Jill
AU - DiFrancesco, Robin
AU - Zingman, Barry S.
AU - Reichman, Richard C.
AU - Fischl, Margaret A.
AU - Gripshover, Barbara
AU - Morse, Gene D.
PY - 2007/2
Y1 - 2007/2
N2 - 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.
AB - 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.
KW - Antiretrovirals
KW - Atazanavir
KW - Liquid chromatography
KW - Therapeutic drug monitoring
UR - http://www.scopus.com/inward/record.url?scp=33847107702&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33847107702&partnerID=8YFLogxK
U2 - 10.1097/FTD.0b013e3180318ef3
DO - 10.1097/FTD.0b013e3180318ef3
M3 - Article
C2 - 17304157
AN - SCOPUS:33847107702
SN - 0163-4356
VL - 29
SP - 103
EP - 109
JO - Therapeutic Drug Monitoring
JF - Therapeutic Drug Monitoring
IS - 1
ER -