Liquid chromatography-electrospray tandem mass spectrometry method for determination of indapamide in serum for single/multiple dose bioequivalence studies of sustained release formulations

J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Feb 25;816(1-2):35-40. doi: 10.1016/j.jchromb.2004.11.002.

Abstract

Indapamide and internal standard (5-chloro-2-methoxy-N-[2-(4-sulphamoylphenyl)ethyl]benzamide) were isolated from plasma by a single step liquid-liquid extraction in t-butyl methyl ether. The chromatographic separation was achieved on a reversed-phase C(18) monolithic column with a mobile phase consisting in a methanol/aqueous 0.1% formic acid mixture and a flow rate of 0.8 ml/min, in isocratic conditions, within 11 min. Target compounds were transferred in an ion trap analyzer via an atmospheric pressure electrospray interface (AP-ESI). The mass analyzer was used in a selected reaction monitoring (SRM) mode, in order to enhance on detection selectivity. Whole method produces quantitation limit for indapamide of 1 ng/ml. Method was successfully applied to assess bioequivalence of two sustained release marketed pharmaceutical formulations of indapamide 1.5 mg coated tablets, carried-out in a single/multiple doses, randomized design.

Publication types

  • Validation Study

MeSH terms

  • Antihypertensive Agents / blood*
  • Antihypertensive Agents / pharmacokinetics*
  • Delayed-Action Preparations / analysis
  • Drug Stability
  • Indapamide / administration & dosage
  • Indapamide / blood*
  • Indapamide / pharmacokinetics*
  • Spectrometry, Mass, Electrospray Ionization / methods*
  • Therapeutic Equivalency

Substances

  • Antihypertensive Agents
  • Delayed-Action Preparations
  • Indapamide