Determination of Duloxetine in rat plasma for pharmacokinetic study by de-veloping a highly sensitive method using liquid chromatography-electrospray ionization tandem mass spectrometry

  • Radhe Raman Singh Drug Metabolism and Pharmacokinetics, LGC Promochem Research and Development Ltd, 2nd Stage, Peenya, Bangalore-560 022, India
  • Yogisha Shivarnna Drug Metabolism and Pharmacokinetics, LGC Promochem Research and Development Ltd, 2nd Stage, Peenya, Bangalore-560 022, India
  • Ghulam Samdani Department of Chemistry, Mirza Ghalib College Gaya-823001 India
  • Surya Pal Singh Department of Chemistry, Magadh University Gaya-824234 India

Abstract

A high sensitive, accurate, rapid assay method has been developed and validated for the estimation of duloxetine in rat plasma with liquid chromatography coupled to tandem mass spectrometry with electro spray ionization in the positive-ion mode. The assay procedure involves extraction of duloxetine and phenacetin (internal standard, IS) from rat plasma by protein precipitation method. Chromatographic separation was achieved using a binary gradient using mobile phase acetonitrile and 0.2% formic acid in water delivered at flow rate of 0.50 mL/min on an Atlantis ODS column with a total run time 4.5 min. The MS/MS ion transitions monitored were 298.4® 154.1 for duloxetine and 180.2 ® 110.1 for IS. As per FDA guidelines, method validation and sample analysis were performed and the results met the acceptance criteria. The linearity was obtained over the concentration range of 0.027 to 1072 ng/mL and the lower limit of quantitation achieved was 27 pg/mL. The intra-day and inter-day precisions were in the range of 1.19-9.51 and 1.98-7.60%, respectively. This method was successfully applied to pharmacokinetic study of duloxetine in rats.

Keywords: Duloxetine, LC-MS/MS, method validation, rat plasma, pharmacokinetics

Downloads

Download data is not yet available.
Published
2012-01-25
Citations
How to Cite
Radhe Raman Singh, Yogisha Shivarnna, Ghulam Samdani, & Surya Pal Singh. (2012). Determination of Duloxetine in rat plasma for pharmacokinetic study by de-veloping a highly sensitive method using liquid chromatography-electrospray ionization tandem mass spectrometry. International Journal of Research in Pharmaceutical Sciences, 3(1), 97-105. Retrieved from https://pharmascope.org/index.php/ijrps/article/view/1003
Section
Original Articles
Article Level Metrix
Abstract Views: 20
PDF Downloaded: 16