Journal of Bioanalysis & Biomedicine

SeungHwan Lee

Publications

• Research Article
  Liquid Chromatography Tandem Mass Spectrometry Determination of Bicalutamide in Human Plasma and Application to a Bioequivalence Study
  Author(s): Bora Kim, JunHwa Shim, SeungHwan Lee, Kyung-Sang Yu, Seo Hyun Yoon and Joo-Youn ChoBora Kim, JunHwa Shim, SeungHwan Lee, Kyung-Sang Yu, Seo Hyun Yoon and Joo-Youn Cho
  
  This study aimed to develop a highly sensitive, rapid method to evaluate the pharmacokinetic bioequivalence of two formulations of the anticancer drug, bicalutamide. According to US and Korean regulatory requirements for a bioequivalence test, we developed an achiral, bioanalytical method to determine bicalutamide levels in human plasma. The method included liquid chromatography tandem mass spectrometry in negative mode and was validated with nilutamide as an internal standard. Quantitation was performed for the transition of 429.2 → 255.0 (m/z) for bicalutamide and 316.2 → 273.2 (m/z) for nilutamide. The lower limit of quantitation was 10 ng mL‑1 with a 50 μL plasma sample. This sensitivity was about 8 times higher than current methods in pharmaceuticals and 10 times higher than methods for human plasma samples. The concentrations of seven working standards sho.. Read More»
  DOI: 10.4172/1948-598X.1000051

  Abstract PDF