This is an outdated version published on 07-03-2026. Read the most recent version.

UV Spectrophotometric method for quantitative determination of Agomelatine in coated tablets

Authors

  • Fábio de Souza Barbosa Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal do Rio Grande do Sul
  • Vanise Coty Rodrigues Faculdade de Farmácia da Universidade Federal do Rio Grande do Sul
  • Nadia Maria Volpato Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal do Rio Grande do Sul
  • Elfrides E. S. Schapoval Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal do Rio Grande do Sul
  • Martin Steppe Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal do Rio Grande do Sul
  • Cássia V. Garcia Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal do Rio Grande do Sul
  • Andreas S. L. Mendez Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal do Rio Grande do Sul

DOI:

https://doi.org/10.22456/2527-2616.79219

Keywords:

agomelatine, UV spectrophotometry, validation, quantitation

Abstract

UV spectrophotometry is an analytical technique used routinely for qualitative and quantitative assay due the low cost and reliability during analysis. In this work, it was validated a quantitative UV method for determination of agomelatine in coated tablets. The parameters specificity, linearity, precision, accuracy and robustness were evaluated according to official guidelines. Methanol was selected as solvent and the maximum wavelength for drug analysis was 230 nm. The purposed assay showed to be specific and the linearity was proved in a range of 0.5 - 2.5 µg/mL. The RSD values obtained during precision assay (inter-day RSD = 1.75%) indicated the method reproducibility, and the accuracy testing showed good results from recovery test. Robustness assay was complementary and showed that the purposed method is adequate for drug quantitation in commercial samples, being a reliable alternative to chromatographic assay.

Downloads

Download data is not yet available.

References

Racagni G, Riva MA, Molteni R, Musazzi L, Calabrese F, Popoli M, Tardito D. Mode of action of agomelatine: Synergy between melatonergic and 5-HT2C receptors. World J Biol Psychiatry. 2011; 12: 574 – 587. DOI: https://doi.org/10.3109/15622975.2011.595823

Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder. CNS Drugs. 2010; 24: 479–499. DOI: https://doi.org/10.2165/11534420-000000000-00000

Millan MJ, Gobert A, Lejene F, Dekeyne A, Newman-Tancredi A, Pasteau V, Rivet JM, Cussac D. The Novel Melatonin Agonist Agomelatine (S20098) Is an Antagonist at 5-Hydroxytryptamine2C Receptors, Blockade of Which Enhances the Activity of Frontocortical Dopaminergic and Adrenergic Pathways. J Pharmacol Exp Ther. 2003: 306: 954–964. DOI: https://doi.org/10.1124/jpet.103.051797

Demyttenaere K. Agomelatine: A narrative review. Eur Neuropsychopharmacol. 2011; 21: 703 – 709. DOI: https://doi.org/10.1016/j.euroneuro.2011.07.004

Hale A, Corralb RM, Mencaccic C, Ruizd JS, Severoe CA, Gentilf V. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. Int Clin Psychopharmacol. 2010; 25: 305. DOI: https://doi.org/10.1097/YIC.0b013e32833a86aa

Kennedy SH, Rizvi S, Fulton, K, Rasmussen JJ. A Double-Blind Comparison of Sexual Functioning, Antidepressant Efficacy, and Tolerability Between Agomelatine and Venlafaxine XR. Clin Psychopharmacol. 2008; 28: 329 - 333. DOI: https://doi.org/10.1097/JCP.0b013e318172b48c

Salaman P, Ramon C, Tesson N, Lydia CR, Marçal CC. European Patent Application. (EP 2 551 257 A1). 2013.

BRASIL. Agência Nacional de Vigilância Sanitária. Resolução - RDC nº 7, de 26 de fevereiro de 2009.

Patil SR, Nerurkar KK, Kalamkar AM, Pukale V, Mangaonkrc KV, Pingalec SGJ. Validated LC-MS/MS method for quantification of agomelatine in human plasma and its application in a pharmacokinetic study. J Mass Spectrom. 2012; 47: 23 – 28. DOI: https://doi.org/10.1002/jms.2020

Liu Y, Chen L, Ji Y. Quantification and structural elucidation of potential impurities in agomelatine active pharmaceutical ingredient. J Pharm Biomed Anal. 2013; 81: 193 – 201. DOI: https://doi.org/10.1016/j.jpba.2013.04.016

Sagar PV, Shivani P, Sushma E, Rani SS. Stability indicating RP-HPLC method for estimation of agomelatine in tablete dosage form. Int J Pharm Biol Sci. 2015; 5: 74 – 81.

BRASIL. Agência Nacional de Vigilância Sanitária. Resolução - RE nº 166, de 24 de julho de 2017.

ICH. Harmonised Tripartite Guideline. Validation of Analytical methods text and methodology Q2(R1). In: Internacional Conference on Harmonization of Technical Requirenments for Registration of Pharmaceuticals for Human Use, 2005

BRASIL. Farmacopéia Brasileira. 5ª ed. Brasília: Agência Nacional de Vigilância Sanitária. 2010.

Fregonezi-Nery MM, Baracat MM, Casagrande R, Machado HT, Miglioranza B, Gianotto EAS. Validação de métodos para determinação de fluoxetina em cápsulas. Quim Nova. 2008; 31: 1665 – 1669. DOI: https://doi.org/10.1590/S0100-40422008000700012

Costa MAB, Ricci-Júnior E, Santos EP, Mansur CRE, Campos VEB. Desenvolvimento e validação de método analítico para a determinação de sulfassalazina em suspensão oral: comparação do método espectrofotométrico e de cromatografia líquida de alta eficiência (CLAE). Quim Nova. 2012; 35: 808 – 813. DOI: https://doi.org/10.1590/S0100-40422012000400028

Mendez ASL, Cassol JPE, Camargo VB, Malesuik MD, Garcia CV. Quantitative Determination of Paliperidone in OROS® Tablets by Derivative Spectrophotometric Method – Application in Extraction and Comparison to HPLC. Curr Anal Chem. 2014; 10: 158 – 165. DOI: https://doi.org/10.2174/1573411011410010014

Bitencourt AS, Oliveira SS, Mendez ASL, Garcia CV. UV spectrophotometric method for determination of posaconazole: comparison to HPLC. Rev Ciênc Farm Básica Apl. 2015; 36: 491 – 495.

Ojeda C, Rojas F. Recent developments in derivative ultraviolet/visible absorption spectrophotometry. Anal Chim Acta. 2004; 518:1 - 24. DOI: https://doi.org/10.1016/j.aca.2004.05.036

Rojas F, Ojeda C. Recent development in derivative ultraviolet/visible absorption spectrophotometry: 2004–2008: A review. Anal Chim Acta. 2009; 635: 22 - 44. DOI: https://doi.org/10.1016/j.aca.2008.12.039

Downloads

Published

28-12-2017 — Updated on 07-03-2026

Versions

How to Cite

de Souza Barbosa, F., Coty Rodrigues, V., Volpato, N. M., S. Schapoval, E. E., Steppe, M., Garcia, C. V., & L. Mendez, A. S. (2026). UV Spectrophotometric method for quantitative determination of Agomelatine in coated tablets. Drug Analytical Research, 1(2), 24–29. https://doi.org/10.22456/2527-2616.79219 (Original work published December 28, 2017)

Issue

Section

ORIGINAL ARTICLES