UV Spectrophotometric method for quantitative determination of Agomelatine in coated tablets
DOI:
https://doi.org/10.22456/2527-2616.79219Keywords:
agomelatine, UV spectrophotometry, validation, quantitationAbstract
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.
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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.
Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder. CNS Drugs. 2010; 24: 479–499.
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.
Demyttenaere K. Agomelatine: A narrative review. Eur Neuropsychopharmacol. 2011; 21: 703 – 709.
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.
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.
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.
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.
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.
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.
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.
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.
Rojas F, Ojeda C. Recent development in derivative ultraviolet/visible absorption spectrophotometry: 2004–2008: A review. Anal Chim Acta. 2009; 635: 22 - 44.
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