A sensitive LC-ESI-MS method for the determination of indapamide in human plasma: method and clinical applications

J Pharm Biomed Anal. 2006 Sep 18;42(2):213-7. doi: 10.1016/j.jpba.2006.03.039. Epub 2006 Jun 16.

Abstract

A sensitive LC-ESI-MS method for the determination of indapamide in human plasma using glibenclamide as the internal standard (IS) was established. Following acidification with 1 M hydrochloric acid solution, plasma samples were extracted with ethyl acetate and separated on a C(18) column with a mobile phase of 10 mM ammonium acetate-methanol (22:78, v/v). Indapamide was determined using electrospray ionization in a single quadrupole mass spectrometer. LC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 364.3 for indapamide and m/z 492.4 for the IS. Calibration curves were linear over the ranges of 0.1-100 ng/ml for indapamide. The lower limit of quantification was 0.1 ng/ml. The intra- and inter-assay precisions were less than 9.5% and 10.6%, respectively. The mean plasma extraction recovery of indapamide was 90.5-93.9%. The method has been successfully applied to study the pharmacokinetics of indapamide in healthy male Chinese volunteers.

MeSH terms

  • Administration, Oral
  • Antihypertensive Agents / blood*
  • Antihypertensive Agents / pharmacokinetics
  • Calibration
  • Chromatography, Liquid / methods
  • Clinical Chemistry Tests
  • Drug Stability
  • Drug Storage
  • Humans
  • Indapamide / blood*
  • Indapamide / pharmacokinetics
  • Male
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrometry, Mass, Electrospray Ionization / methods

Substances

  • Antihypertensive Agents
  • Indapamide