Simultaneous determination of atorvastatin and niacin in human plasma by LC-MS/MS and its application to a human pharmacokinetic study.

摘要: A rapid, simple, sensitive and selective LC-MS/MS method has been developed validated for quantification of the atorvastatin (AT) niacin (NA) in 250 μL human plasma. The analytical procedure involves a liquid–liquid extraction using nevirapine as an internal standard (IS). chromatographic separation was achieved on Hypurity Advance (4.6 × 50 mm, 5 µm) column mobile phase consisting 0.1% formic acid buffer–acetonitrile (20:80, v/v) at flow rate 0.8 mL/min. API-4000 operated multiple-reaction monitoring mode electrospray ionization. total run time analysis 3 min elution AT, NA IS occurred 1.06, 1.84 0.92 min, respectively. detailed validation performed per US Food Drug Administration guidelines curves found to be linear range 0.10–30.0 ng/mL AT 20.2–6026 ng/mL NA, with coefficient correlation ≥0.99 both compounds. were stable battery stability studies, viz. bench-top, autosampler, re-injection, wet-extract repeated freeze–thaw cycles. assay successfully applied pharmacokinetic study humans. Copyright © 2012 John Wiley & Sons, Ltd.