Development and validation of a bioanalytical method for five antidepressants in human milk by LC-MS

J Pharm Biomed Anal. 2016 Sep 10:129:502-508. doi: 10.1016/j.jpba.2016.07.047. Epub 2016 Jul 30.

Abstract

The use of medications during lactation is a common practice; however, pharmacological treatments impose serious doubts to both professionals and nursing mothers regarding the safety of drugs used during this period. Most of drugs are excreted in breast milk and there is great variability in the amount of analytes that can be received by the infant. Dilemmas about breastfeeding arise most commonly in relation to postpartum depression. Depression is a major clinical problem during the postpartum period and the vulnerability to onset or recurrence of depressive symptoms increases the possibility of psychotropic drug use during lactation. Selective inhibitors of serotonin reuptake are commonly prescribed for the treatment of depressive disorders, including fluoxetine, sertraline, citalopram, and paroxetine. A validated bioanalytical method using liquid chromatography coupled to mass spectrometry was developed and validated for determination of antidepressants in human milk following protein precipation. The bioanalytical method was successfully applied to assess milk samples from nursing mothers. From found concentrations, infant absolute (4.36-12.26μg/kg/day) and relative dose (0.60-2.90%,) were estimated and low values were obtained indicating safe use during laction. However, other factors such as complemantary feeding and hepatic or renal disorders in the infant should be considered.

Keywords: Antidepressants; Excretion; Human milk; Selective inhibitors of serotonin reuptake.

MeSH terms

  • Antidepressive Agents / adverse effects
  • Antidepressive Agents / chemistry*
  • Antidepressive Agents / therapeutic use
  • Biological Assay / methods*
  • Breast Feeding / methods
  • Chromatography, Liquid / methods
  • Depression, Postpartum / drug therapy
  • Female
  • Humans
  • Infant
  • Lactation / drug effects
  • Mass Spectrometry / methods
  • Milk, Human / chemistry*
  • Technology, Pharmaceutical / methods*

Substances

  • Antidepressive Agents