Validation of HPLC, a method for the quantitative determination of an active substance in a therapeutic and prophylactic drug

This paper discusses the principles and methodology of validation of an analytical method based on high performance liquid chromatography (HPLC) used for quality control and quantitative determination of the active substance in an anthelmintic drug.
Key validation parameters such as specificity, linearity, accuracy, precision, detection limit, and quantification limit are described. The analysis made it possible to confirm the compliance of the method with the requirements of regulatory documentation, which ensures its suitability for subsequent quality control of the drug. The results obtained indicate the high reliability and reproducibility of the HPLC method in the conditions of laboratory control of pharmaceutical products. It has been established that for all the parameters presented, the method meets the requirements of regulatory documents.

1. YAshin YA.I., YAshin A.YA. Vysokoeffektivnaya zhidkostnaya hromatografiya. Sostoyanie i perspektivy. Ros. him. zhurnal.2002; 47 (4): 64-79.

2. SHapovalov E.N. Pirogov A.V. Hromatograficheskie metody analiza. -M.: MGU im M.V. Lomonosova, 2007. 109 s

3. Blum F. High performance liquid chromatography. Br J Hosp Med (Lond). 2014 Feb;75(2):C18-21. doi: 10.12968/hmed.2014.75.Sup2.C18. PMID: 24521830.

4. Sobolewska E, Biesaga M. High-Performance Liquid Chromatography Methods for Determining the Purity of Drugs with Weak UV Chromophores - A Review. Crit Rev Anal Chem. 2025;55(3):419-433. doi: 10.1080/10408347.2023.2291815. Epub 2024 Jan 5. PMID: 38180794.

5. Cvet M S Tr Varshavskogo obva estestvoispytatelej Otd biol , 1903, t 14, s 1

6. Biryukov A.A. Zooantroponoznye zabolevaniya cheloveka // Veterinarnaya klinika. Ekaterinburg, 2003. - №10 (17). - S. 32-34.

7. Ignatova D.YU. Epizootologicheskij monitoring pri parazitozah sobak: epizootologicheskie parametry parazitozov sobak: diss. ... kand. vet. nauk. Nizhnij Novgorod, 2007. 149 s.

8. Kryuchkova E.N. Ekologiya gel'mintov u domashnih i dikih plotoyadnyh zhivotnyh v evropejskoj chasti Rossijskoj Federacii: diss. ... dokt. vet. nauk. Ivanovo, 2012. 311 s.