ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

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

Sakine Atila Karaca, Nurana Rashidova, Alper Uğur, and Duygu Yeniceli Uğur

Department of Analytical Chemistry, Faculty of Pharmacy, Anadolu University, Eskisehir, Turkey

E-mail: dyeniceli@anadolu.edu.tr

Received: 12 September 2019  Accepted: 20 November 2019

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

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-019-01008-0

Chemical Papers 74 (5) 1541–1549 (2020)