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




quetiapine fumarate, forensic pharmaceutical expertise, spectral analysis, chromatography


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

Author Biographies

Olena Bevz, National University of Pharmacy

PhD, Assistant

Department of Medicinal Chemistry

Igor Sych, National Scientific Center «Hon. Prof. M. S. Bokarius Forensic Science Institute»

PhD, Head of the physical and chemical Research Sector Forensic Research Laboratory

Angelina Shaposhnyk, V. N. Karazin Kharkiv National University

PhD, Associate Professor

Department of Natural Disciplines International

Irina Sych, National University of Pharmacy

PhD, Associate Professor

Department of Medicinal Chemistry

Olga Kryvanych, Uzhgorod National University

PhD, Associate Professor

Department of Pharmaceutical Disciplines

Svitlana Taran, National University of Pharmacy

Doctor of Pharmaceutical Science, Professor

Department of Medicinal Chemistry

Lina Perekhoda, National University of Pharmacy

Doctor of Pharmaceutical Science, Professor, Head of Department

Department of Medicinal Chemistry


  1. Falsyfikatsiia ta obih falsyfikovanykh likarskykh zasobiv: kryminalno-pravove doslidzhennia (2013). Odesa: Vydavnychyi dim «Helvetyka», 232.
  2. Kalyniak, M., Blavatska, O. Problema yakosti ta bezpeky likarskykh zasobiv. Falsyfikatsiia ta kontrol yakosti.
  3. Iqbal, Y., Connell, C., Worthington, M., Elrafei, H., Mulvaney, C., Kaewchaluay, C. (2019). Quetiapine dose for people with schizophrenia. Cochrane Database Of Systematic Reviews, 7, 15. doi:
  4. Vieta, E. (2013). Quetiapine in Bipolar DepressionContents. Quetiapine in Bipolar Depression, 5–86. doi:
  5. Brett, J. (2015). Concerns about quetiapine. Australian Prescriber, 38 (3), 95–97. doi:
  6. Derzhavnyi reiestr likarskykh zasobiv Ukrainy. Available at: %EA %E2 %E5 %F2 %B3 %E0 %EF %B3 %ED
  7. Reiestr dokumentiv shchodo yakosti LZ. Available at:
  8. Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
  9. Pro sudovu ekspertyzu (1994). Zakon Ukrainy No. 4038-XII. 25.02.1994. Available at:
  10. Ministerstvo yustytsii Ukrainy. Reiestr metodyk provedennia sudovykh ekspertyz. Available at:
  11. Guidelines on Representative Drug Sampling (2009). New York: United Nations, 44.
  12. Rapid testing methods of drugs of abuse (1994). United nations international drug control programme. New York: United Nations, 105.
  13. Basavaiah, K., Rajendra Prasad, N., Ramesh, P. J., Vinay, K. B. (2010). Sensitive and selective extraction-free spectrophotometric determination of quetiapine fumarate in pharmaceuticals using two sulphonthalein dyes. Journal of Pre-Clinical and Chemical Research, 4 (1), 24–31.
  14. Islam, M. M., Mahmoud, A. O., Dalia, M. N., Sayed, M. D. (2018). Analysis of quetiapine in human plasma using fluorescence spectroscopy. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 196, 196–201. doi:
  15. Sathiya, R., Krishnaraj, K., Muralidharan, S., Muruganantham, N. (2010). A Simple and Validated HPTLC Method of Evaluation for Quetiapine fumarate in Oral Solid Dosage Form. Eurasian Journal Of Analytical Chemistry, 5, 246–253.
  16. Bavirisetti, K., Battula, S., Shankar Dubey, S. (2013). Validation of Quetiapine Fumarate in Pharmaceutical Dosage by Reverse-Phase HPLC with Internal Standard Method. Journal of Chemistry, 2013, 1–8. doi:
  17. Belova, M. V., Klyuyev, E. A., Melnikov, E. S., Poryadina, M. N. (2020). Chemical and Toxicological Diagnosis of Acute Poisoning with Clozapine, Olanzapine, Quetiapine and Risperidone. Russian Sklifosovsky Journal of Emergency Medical Care, 9 (2), 188–194. doi:
  18. ICH Harmonized Tripartite Guideline: Q8 (R2) on pharmaceutical development (2017). The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), 24
  19. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty- first report (2007). WHO Technical Report Series, No. 943. Geneva: World Health Organization.
  20. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Vol. 2. Second updated edition. Good manufacturing practices and inspection (2007). Geneva: World Health Organization, 46.
  21. Deepak, S., Rana, A. C. (2010). Formulation development of Quetiapine Fumarate SR matrix tablets. Der Pharmacia Sinica, 1 (1), 48–57.
  22. Merzlikin, S. I., Kucher, T. V., Stepanenko, V. I., Pogosyan, O. H., Golik, M. Yu. (2020). Application of thin layer chromatography for the analytical diagnostics of combined prochlorperazine poisonings. Journal of Organic and Pharmaceutical Chemistry, 18 (2 (70)), 54–58. doi:
  23. The European Pharmacopoeia (2018). European Directorate for the Quality of Medicines & HealthCare of the Council of Europe. Strasbourg, 6. Available at:
  24. Ciura, K., Rutecka, A., Szewczyk, A., Nowakowska J., Kawczak, P., Bączek, T. (2019). Study of the chromatographic behavior of selected antipsychotic drugs on RP-TLC based on quantitative structure–retention relationships. Journal of the Iranian Chemical Society, 16 (5), 1019–1027, doi:
  25. Anand, B. K., Ch. Saila, P., Kotapadu, A., Chitra, K. (2014). A facile UV spectrophotometric estimation of quetiapine fumarate in pharmaceutical dosage form. Journal of Pharmacy Research, 8 (10), 1341–1343.
  26. Eapen, S. C., Velekkat, P., Kutty, S. V., Jyothi, T. S. (2011). Development and validation of UV-spectrophotometric method for determination of quetiapine fumarate in pure and pharmaceutical formulation. International Journal of Pharmacy and Technology, 3, 3535–3542.
  27. Vinay, K., Revanasiddappa, H., Ramesh, P., Rajendraprasad, N. (2011). Titrimetric and sensitive spectrophotometric methods for the assay of Quetiapine fumarate in pharmaceutical formulations. Chemical Industry and Chemical Engineering Quarterly, 17 (1), 99–106. doi:
  28. Xiujuan, C., Chen, L., Lijun, C., Jian, L., Zheyuan, Q., Runsheng, Z. et. al. (2019). A rapid LC-MS/MS method for simultaneous determination of quetiapine and duloxetine in rat plasma and its application to pharmacokinetic interaction study. Journal of Food and Drug Analysis, 27 (1), 323–331. doi:




How to Cite

Bevz, O., Sych, I., Shaposhnyk, A., Sych, I., Kryvanych, O., Taran, S. ., & Perekhoda, L. (2021). Development of determination methods of quetiapine fumarate for forensic-pharmaceutical purposes. ScienceRise: Pharmaceutical Science, (2 (30), 4–12.



Pharmaceutical Science