Development of a bioanalytical method for analysis of duloxetine in biological fluids of laboratory animals

Remezova I. P.¹
Dr. Sci. (Pharm.), Professor, Professor of the Department of Pharmaceutical and Toxicological Chemistry named after A.P. Arzamastsev, Institute of Pharmacy named after A.P. Nelyubin;
ORCID: 0000-0003-3456-8553; SPIN: 9014-5728

Pozdnyakov D. I.²
Dr. Sci. (Pharm.), Associate Professor, Head of the Department of Pharmacology with a Course in Clinical Pharmacology;
ORCID: 0000-0002-5595-8182; SPIN: 6764-0279

Durnova N. A.¹
Dr. Sci. (Biol.), Associate Professor, Professor of the Department of Pharmaceutical Natural Science, Institute of Pharmacy named after A.P. Nelyubin;
ORCID: 0000-0003-4628-9519; SPIN: 3348-2957

1Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenovskiy University), Moscow, Russia
2Pyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University, Ministry of Health of Russia, Pyatigorsk, Stavropol Krai, Russia

Irina P. Remezova, e-mail: remezova_i_p@staff.sechenov.ru

The study was conducted without sponsorship.

The authors declare no conflict of interest.

30.04.2026

15.08.2026

Introduction. The relevance of the study is determined by the need to improve methods for the quantitative determination of duloxetine, a modern antidepressant, in biological objects to optimize therapeutic monitoring and toxicological diagnostics. Monitoring drug concentrations in the patient's body is necessary due to individual metabolic characteristics, the risk of side effects, and the possibility of overdose. Objective. To develop and validate a bioanalytical method for the quantitative determination of duloxetine in biological fluids of laboratory animals using high-performance liquid chromatography (HPLC). Materials and Methods. The study used the pharmaceutical product «Duloxetine Canon» as the test object and Duloxetine Hydrochloride reference standard (Supelco) for calibration. Experiments were carried out on 30 Wistar rats that received the drug intragastrically at a dose of 300 mg/kg; serum and urine samples were collected for analysis. A sample preparation procedure using liquid-liquid extraction was developed; chromatographic conditions were optimized (mobile phase acetonitrile–phosphate buffer, detection at 231 nm). Validation was performed for selectivity, linearity, limit of quantification, accuracy, precision, stability, and matrix effect. Results. The method has a limit of quantification of 6 μg/mL, a linear range of 6–160 μg/mL, and a relative error of no more than ±1.57%. The developed approach effectively determines duloxetine in blood serum and urine at 30, 60, and 180 min after administration, which expands the possibilities of toxicological monitoring. For chemical-toxicological analysis of a toxic dose of duloxetine, it is advisable to examine both biological fluids. Conclusion. The created tool can be used for monitoring therapeutic concentrations and diagnosing poisoning, which contributes to the safe use of duloxetine in clinical practice. The method is suitable for both diagnostic purposes and scientific research in the pharmacokinetics of antidepressants.

duloxetine, bioanalytical method, high-performance liquid chromatography, laboratory animals, method validation

10.29234/2308-9113-2026-14-3-58-71

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