Simple, sensitive and rapid LC-MS method for the quantitation of indapamide in human plasma--application to pharmacokinetic studies

J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Sep 14;842(1):58-63. doi: 10.1016/j.jchromb.2006.03.024. Epub 2006 Jul 14.

Abstract

A sensitive and specific method using liquid chromatography with electrospray ionization mass spectrometry (LC-ESI-MS) has been developed and validated for the identification and quantification of indapamide in human plasma. A simple liquid-liquid extraction procedure was followed by injection of the extracts on to a C18 column with gradient elution and detection using a single quadrupole mass spectrometer in selected ion monitoring (SIM) mode. The method was tested using six different plasma batches. Linearity was established for the concentration range 0.5-100.0 ng/ml, with a coefficient of determination (r) of 0.9998 and good back-calculated accuracy and precision. The intra- and inter-day precision (RSD%) was lower than 10%, and accuracy ranged from 85 to 115%. The lower limit of quantification was reproducible at 0.2 ng/ml with 0.2 ml plasma. The proposed method enables the unambiguous identification and quantification of indapamide for pre-clinical and clinical studies.

Publication types

  • Randomized Controlled Trial
  • Validation Study

MeSH terms

  • Antihypertensive Agents / blood*
  • Antihypertensive Agents / pharmacokinetics
  • Calibration
  • Chromatography, High Pressure Liquid / methods*
  • Cross-Over Studies
  • Humans
  • Indapamide / blood*
  • Indapamide / pharmacokinetics
  • Male
  • Reference Standards
  • Sensitivity and Specificity

Substances

  • Antihypertensive Agents
  • Indapamide