Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS.

Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. Research Abstract Details 

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Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. Abstract Text:

S A Merschman,P T Vallano,L A Wenning,B K Matuszewski,E J Woolf,S A Merschman,P T Vallano,L A Wenning,B K Matuszewski,E J Woolf,

An HPLC-MS/MS method was developed for the determination of MK-0518 (raltegravir), an HIV integrase inhibitor, in human plasma over the concentration range of 2-1000 ng/mL. Stable isotope labeled (13)C(6)-MK-0518 was used as an internal standard. The sample preparation procedure utilized liquid-liquid extraction with hexane:methylene chloride in the 96-well format with a 200 microL plasma sample size. The compounds were chromatographed on an Ace C(18) (50 x 3.0 mm, 3 microm, titanium frits) column with 42.5/57.5 (v/v %) 0.1mM EDTA in 0.1% formic acid/methanol mobile phase at a flow rate of 0.5 mL/min. Multiple reaction monitoring of the precursor-to-product ion pairs for MK-0518 (m/z 445-->109) and (13)C(6)-MK-0518 (m/z 451-->367) on an Applied Biosystem API 4000 HPLC-MS/MS was used for quantitation. Intraday precision of standard curve concentrations in five different lots of control plasma was within 3.2%, while accuracy ranged from 94.8 to 106.8%. The mean extraction recovery of spiked plasma samples was 87%. Quality control (QC) samples were stored at -20 degrees C. Initial within day analysis showed QC accuracy within 7.5% of nominal with precision of 3.1% or less. The plasma QC samples were demonstrated to be stable for up to 23 months at -20 degrees C. The method described has been used to support over 18 clinical studies during Phase I through III of clinical development.

Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. Publishing Authors By Initials

SA Merschman,PT Vallano,LA Wenning,BK Matuszewski,EJ Woolf,SA Merschman,PT Vallano,LA Wenning,BK Matuszewski,EJ Woolf,

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Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Journal of chromatography. B, Analytical technolog

VOLUME: 857

Page Numbers: 15-24

Journal Abbreviation: J. Chromatogr. B Analyt. Techn

ISSN: 1570-0232

DAY: 5

MONTH: 07

YEAR: 2007

Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. Information

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LANGUAGE: eng

NlmUniqueID: 101139554

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Grant and Affiliation Information for Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS.

AFFILIATION: Department of Drug Metabolism, Merck Research Laboratories, WP75B-300, West Point, PA 19486, USA. sheila_merschman@merck.com

Country: Netherlands

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MEDLINETA: J Chromatogr B Analyt Technol

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