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Atazanavir (ATV) is a protease inhibitor used in combination antiretroviral therapy (ART). We developed and validated a liquid chromatography\/tandem mass spectrometry (LC\/MS\/MS)\u2010based method to quantify ATV in human hair, per the NIH Division of AIDS Clinical Pharmacology Quality Assurance (CPQA) program and the FDA bioanalytical method validation guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      ATV was extracted from hair using optimized methods and the extracts were injected onto a BDS C\u201018 column (5\u00a0\u03bcm, 4.6 \u00d7 100\u00a0mm), followed by isocratic elution via a mobile phase composed of 55% acetonitrile, 45% water, 0.15% acetic acid, and 4\u00a0mM ammonium acetate, at a flow rate of 0.8\u00a0mL\/min prior to analysis by MS\/MS. Levels were quantified using positive electrospray ionization by multiple reaction monitoring (MRM) for the transitions MH\n                      <jats:sup>+<\/jats:sup>\n                      <jats:italic>m\/z<\/jats:italic>\n                      705.3 to\n                      <jats:italic>m\/z<\/jats:italic>\n                      168.0 and MH\n                      <jats:sup>+<\/jats:sup>\n                      <jats:italic>m\/z<\/jats:italic>\n                      710.2 to\n                      <jats:italic>m\/z<\/jats:italic>\n                      168.0 for ATV and ATV\u2010d5 (internal standard), respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Our assay demonstrated a linear standard curve (r = 0.99) over the concentration range of 0.0500\u00a0ng ATV\/mg hair to 20.0\u00a0ng\/mg hair. The inter\u2010 and intraday accuracy of ATV quality control (QC) samples was \u22121.33 to 4.00% and precision (% coefficient of variation (%CV)) was 1.75 to 6.31%. The %CV for ATV levels in hair samples from highly adherent patients (incurred samples) was less than 10%. No significant endogenous peaks or crosstalk were observed in the specificity test with other HIV drugs. The overall extraction efficiency of ATV from incurred hair samples was greater than 95%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This highly sensitive, highly specific and validated assay can be considered for therapeutic drug monitoring for HIV\u2010infected patients on ATV\u2010based ART.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rcm.8058","type":"journal-article","created":{"date-parts":[[2018,1,10]],"date-time":"2018-01-10T07:49:14Z","timestamp":1515570554000},"page":"431-441","source":"Crossref","is-referenced-by-count":12,"title":["Development and validation of an assay to analyze atazanavir in human hair via liquid chromatography\/tandem mass 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