Liquid Chromatography-Tandem Mass Spectrometric Assay for Determination of Stavudine in Human Plasma. (17th June 2014)

• Record Type: Journal Article
• Authors: Jin, Fengdan
• Other Names: Wu Bing Academic Editor.
• Is Part Of: Journal of spectroscopy. Volume 2014(2014)
• Publication Date: 2014-06-17
• Subjects: Spectrum analysis -- Periodicals; 543.505
• DOI: 10.1155/2014/517089
• Languages: English
• ISSNs: 2314-4920

Abstract

Abstract : A LC-MS/MS method for determination of stavudine in human plasma was established and validated, and it was applied to the pharmaceutical formulations bioequivalence study. 0.5 mL plasma sample was extracted by liquid-liquid extraction. Stavudine was detected by a LC-MS/MS system. The pharmacokinetic parameters of stavudine in different formulations were calculated by noncompartment model statistics. The method was linear over the concentration ranges 5.00–1000 ng/mL in plasma. The intra- and interassay relative standard deviation (RSD) was <10%. The average accuracies for the assay at three concentrations (5.00, 80.0, and 900 ng/mL) were from 100.2% to 102.5%. Pharmacokinetic parameters of stavudine reference formulation were obtained as follows: T m a x was 0.6 ± 0.2 h, C m a x was 480.7 ± 150.9 g/L, t 1/2 was 1.7 ± 0.4 h, and AU C 0 - t was 872.8 ± 227.8 g·h/L, and pharmacokinetic parameters of stavudine test formulation were obtained as follows: T m a x was 0.5 ± 0.2 h, C m a x was 537.5 ± 178.5 g/L, t 1/2 was 1.7 ± 0.3 h, and AU C 0 - t was (914.1 ± 284.5 ) g·h/L. Calculated with AU C 0 - t, the bioavailability of two formulations was 105.0%.