Development of determination methods of quetiapine fumarate for forensic-pharmaceutical purposes


Olena Bevz, Igor Sych, Angelina Shaposhnyk, Irina Sych, Olga Kryvanych, Svitlana Taran, Lina Perekhoda

Abstract

Quetiapine fumarate (an antipsychotic) is part of numerous generic drugs that are in fairly wide demand among the population, therefore, more and more data appear on the counterfeiting and smuggling of funds, as well as non-medical use, which are life-threatening for the population and explain the high prevalence of the active ingredient as object of forensic examination.

The aim. To develop an algorithm for conducting a forensic pharmaceutical examination and propose a method for determining quetiapine fumarate for forensic pharmaceutical purposes.

Materials and methods. All studies were performed using reagents that meet the EP, USP and USPU requirements, Class A glassware and qualified devices.

Identification by IR spectroscopy was performed in the range from 500 to 4000 cm-1 on the device “Nicolet 380 FT-IR Spectrometer by Thermo Fisher Scientific” using a prefix “Smart Perfomer” with a ZnSe crystal.

The UV absorption spectra of the solutions were recorded using a Specord 205 spectrophotometer from Analytik Jena AG (Germany).

TLC was performed on Merck chromatographic plates (silica gel 60G F254, Germany). The following systems were used as mobile phases: hexane – acetone – 25 % ammonia solution (60: 40: 2); methanol – 25 % ammonia solution (100: 1.5), hexane – acetone – 25 % ammonia solution (50: 45: 5). Detection was performed under UV light (254 nm), followed by spraying with Dragendorff reagent.

Analysis by gas chromatography with mass detection was performed using a GC gas chromatograph with a mass spectrometric detector GCMS-QP2020. Data were analyzed using the program: GCMSsolution, LabSolutions Insight (Shimadzu Corporation, Tokyo, Japan).

Results. An algorithm for conducting a forensic pharmaceutical examination in accordance with the current legislation of Ukraine has been developed, methods for determining quetiapine for forensic pharmaceutical purposes have been proposed.

Conclusions. The developed methods for determining quetiapine meet the requirements of the current legislation of Ukraine and the Ministry of Justice of Ukraine. The obtained data prove the high sensitivity and reproducibility of the methods and prove the possibility of their introduction into the practice of forensic examination