Determination of ampicillin in human plasma by solid-phase extraction-liquid chromatography-tandem mass spectrometry (SPE-LC-MS/MS) and its use in bioequivalence studies

Arzneimittelforschung. 2008;58(2):91-6. doi: 10.1055/s-0031-1296474.

Abstract

A simple, fast, sensitive and selective solid-phase extraction-liquid chromatography-tandem mass spectrometry (SPE-LC-MS/MS) method for the quantitative analysis of ampicillin (CAS 69-53-4) in human plasma was developed using amoxicillin as internal standard, and sample extraction by solid-phase extraction (SPE). Extracts were separated by reversed-phase C18 with aqueous mobile phase (acetonitrile, 80:20, v/v) with 0.1% formic acid. The method was validated and successfully applied in a bioequivalence study of capsules 500 mg of ampicillin. Using a short running time of 2.5 min, the lower limit of quantification (LLOQ) for obtained ampicillin was 0.1 microg/ml for a plasma sample of 250 microl and a recovery of 94.38% +/- 4.05. Bioequivalence between the products was determined by calculating 90% confidence intervals (CI) for the ratio of Cmax, AUC0-t and AUC0-inf values for the test and reference products, which were within the 0.80-1.25 interval proposed by FDA and EMEA. It is concluded that the two formulations are bioequivalent in their rate and extent of absorption, and thus, may be used interchangeably.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Amoxicillin / blood
  • Ampicillin / blood*
  • Ampicillin / pharmacokinetics*
  • Anti-Bacterial Agents / blood*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Calibration
  • Chromatography, Liquid
  • Cross-Over Studies
  • Double-Blind Method
  • Humans
  • Indicators and Reagents
  • Male
  • Quality Control
  • Reproducibility of Results
  • Solid Phase Extraction
  • Tandem Mass Spectrometry
  • Therapeutic Equivalency

Substances

  • Anti-Bacterial Agents
  • Indicators and Reagents
  • Ampicillin
  • Amoxicillin