Development and validation of a method for the determination of nicotinic acid in human plasma using liquid chromatography-negative electrospray ionization tandem mass spectrometry and its application to a bioequivalence study
Abstract
For 60 years, nicotinic acid (NA) has been used as a potent vitamin in milligram doses while NA in gram doses has been administrated as a broad-spectrum lipid drug potent. Therefore, it is critical and important to validate sensitive methods for the analysis of NA in human plasma. Thus, a simple and sensitive LC-MS/MS method has been developed and validated for the quantification of NA in human plasma using quinoline-3-carboxylic acid as an internal standard (IS). Following liquid–liquid extraction (LLE) with n-butanol, the analytes were separated on a Hypersil Gold CN column (4.6 × 150 mm i.d., 5 μm) interfaced with a triple-quadrupole tandem mass spectrometer using negative electrospray ionization. Quantification of NA was conducted by multiple reaction monitoring (MRM) of the transitions at m/z 122.0 → 78.1 for NA and 171.9 → 127.8 for the IS. The lower limit of quantification was 6.57 ng mL−1, and the assay exhibited a linear range of 6.57–5255 ng mL−1. The developed method was successfully applied for a bioequivalence (BE) study in healthy volunteers after oral administration of NA.
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