Determination of nimodipine in human plasma by HPLC-ESI-MS and its application to a bioequivalence study

J Chromatogr Sci. 2010 Feb;48(2):81-5. doi: 10.1093/chromsci/48.2.81.

Abstract

A simple, specific, and precise liquid chromatographic-electrospray ionization mass spectrometric (LC-ESI-MS) method has been developed for determination of nimodipine concentration in human plasma. The method involves the addition of 200 microL of saturated sodium bicarbonate (NaHCO(3)) solution to plasma to improve the extraction recovery, liquid-liquid extraction of nimodipine from plasma samples with anhydrous diethyl ether, simple reversed-phase chromatography, and ESI mass spectrometric detection in negative ion selected ion monitoring mode (SIM) using target [M-] ions at m/z 417 and m/z 359 for nimodipine and nitrendipine (internal standard, IS), respectively. A complete analytical run was achieved within 3.5 min. The limit of quantification was 0.5 ng/mL. The method was validated within a linear range of 0.5-100 ng/mL. The correlation coefficient for the calibration regression line was 0.9995 or better. Intra- and inter-batch accuracy and precision were acceptable. Analyte was stable in a battery of stability studies. The method has been successfully used in a bioequivalence study.

Publication types

  • Validation Study

MeSH terms

  • Calcium Channel Blockers / blood*
  • Calcium Channel Blockers / pharmacokinetics
  • Calibration
  • Chromatography, High Pressure Liquid / methods*
  • Humans
  • Limit of Detection
  • Nimodipine / blood*
  • Nimodipine / pharmacokinetics
  • Spectrometry, Mass, Electrospray Ionization / methods*
  • Therapeutic Equivalency

Substances

  • Calcium Channel Blockers
  • Nimodipine