Development of a HPLC-MS/MS method for the simultaneous determination of nifedipine and lidocaine in human plasma

J Pharm Biomed Anal. 2016 Nov 30:131:13-19. doi: 10.1016/j.jpba.2016.08.004. Epub 2016 Aug 5.

Abstract

The method for simultaneous determination of nifedipine (NIF) and lidocaine (LID) in human plasma by one-step sample preparation has been developed for the first time. Due to the photosensitivity of nifedipine and its low plasma concentrations a precise and reliable method was required. The method involved liquid-liquid extraction (methyl tert-butyl ether, MTBE), and 10μL of the resulting sample was analyzed by HPLC-MS/MS. Chromatographic separation was achieved on an YMC-Triart C18 HPLC column (100×2.0mm; S-5μm 12nm). The mobile phase was methanol:water, 60:40 (v/v) and contained 0.15% acetic acid. The linearity of the method was established in the concentration ranges of 0.5-50ng/mL for NIF and 1.0-500ng/mL for LID. Photodestruction of NIF under ambient light was evaluated. The validated method was successfully applied to analyze human plasma samples after rectal application of the drug (1g) containing 2.0% LID and 0.3% NIF.

Keywords: HPLC–MS/MS; Lidocaine; Liquid–liquid extraction; Nifedipine; Pharmacokinetics; Photosensitivity.

MeSH terms

  • Chromatography, High Pressure Liquid / methods
  • Chromatography, High Pressure Liquid / standards
  • Humans
  • Lidocaine / analysis
  • Lidocaine / blood*
  • Nifedipine / analysis
  • Nifedipine / blood*
  • Reproducibility of Results
  • Tandem Mass Spectrometry / methods*
  • Tandem Mass Spectrometry / standards

Substances

  • Lidocaine
  • Nifedipine