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

Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application. Research Abstract Details 

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Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application. Abstract Text:

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

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 microg/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.

Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application. Publishing Authors By Initials

K Keil,J Hochreitter,R DiFrancesco,BS Zingman,RC Reichman,MA Fischl,B Gripshover,GD Morse,

For similar natural sciences: time: time factors research abstracts see: natural sciences: time: time factors research

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Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application. Journal Published:

PUBLICATION TYPE: Validation Studies

Journal: Therapeutic drug monitoring

VOLUME: 29

Page Numbers: 103-9

Journal Abbreviation:

ISSN: 0163-4356

DAY: 3

MONTH: Feb

YEAR: 2007

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

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LANGUAGE: eng

NlmUniqueID: 7909660

Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application. Keywords Mesh Terms:

KEYWORDS: Time Factors

MESH TERMS: methods

Chemical & Substance for Abstract: Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application. Information

Substance Name: atazanavir

Registry Number: 198904-31-3

Grant and Affiliation Information for Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and application.

AFFILIATION: Pharmacotherapy Research Center, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, New York 14260, USA.

Country: United States

AGENCY: United States NIAID

GRANT: U01-AI138858

ACRONYM: AI

MEDLINETA: Ther Drug Monit

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