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Development of a simple HPLC method for the quantitation of vortioxetine in pharmaceuticals using DoE approach

  • Sakine Atila Karaca
  • Nurana Rashidova
  • Alper Uğur
  • Duygu Yeniceli UğurEmail author
Original Paper
  • 17 Downloads

Abstract

A novel HPLC method was proposed for the quantitation of vortioxetine, which is a new antidepressant drug, in tablets. Separation was performed on a Zorbax Eclipse Plus C18 (3.5 µm particles, 4.6 × 50 mm) column at 35 °C with 1.0 mL/min flow rate and chlorpromazine was selected as internal standard. Box–Behnken design, a design of experiment (DoE) method, was applied to explore the influences of mobile phase pH, acetonitrile content and buffer concentration on chromatographic separation of vortioxetine and chlorpromazine. The optimized conditions were acetate buffer (25 mM, pH:4):acetonitrile (63.5:36.5, v/v). Retention times of chlorpromazine and vortioxetine were 3.8 and 4.6 min, respectively, and a good chromatographic separation was obtained under optimal conditions. Validation studies of the developed method were conducted according to the International Conference on Harmonization (ICH) guideline. The method was linear in the concentration range of 0.5–50 µg/mL. The detection and quantitation limits were 0.080 and 0.264 μg/mL, respectively. Recovery values within 98–102% and relative standard deviation values lower than 2% indicate the precision and accuracy of the method. The method was applied to vortioxetine tablets with no interference.

Graphic abstract

Keywords

Vortioxetine HPLC–DAD Determination DoE Tablet analysis 

Notes

Acknowledgements

The authors gratefully acknowledge the support of the Research Council of Anadolu University for the funding of this study (Project no: 1805S211).

Compliance with ethical standards

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Supplementary material

11696_2019_1008_MOESM1_ESM.docx (18 kb)
Supplementary material 1 (DOCX 18 kb)

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Copyright information

© Institute of Chemistry, Slovak Academy of Sciences 2019

Authors and Affiliations

  1. 1.Department of Analytical Chemistry, Faculty of PharmacyAnadolu UniversityEskisehirTurkey
  2. 2.Department of Materials Science and Engineering, Faculty of EngineeringEskisehir Technical UniversityEskisehirTurkey

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