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Journal of the Chilean Chemical Society

versão On-line ISSN 0717-9707

Resumo

THORAT, S. G; PADMANE, S. P; TAJNE, M. R  e  ITTADWAR, A. M. DEVELOPMENT AND VALIDATION OF SIMPLE, RAPID AND SENSITIVE UV, HPLC AND HPTLC METHODS FOR THE ESTIMATION OF PIRFENIDONE IN TABLET DOSAGE FORM. J. Chil. Chem. Soc. [online]. 2016, vol.61, n.2, pp.2978-2981. ISSN 0717-9707.  http://dx.doi.org/10.4067/S0717-97072016000200025.

UV, HPLC and HPTLC methods were developed and validated for the quantitative determination of Pirfenidone, a novel antifibrotic agent used in idiopathic pulmonary fibrosis. Chromatography was carried out by isocratic technique on reversed phase Eclipse XDB-C18 column (150 x 4.6 mm, 5 μm) with mobile phase consisting of phosphate buff acetonitrile (pH 3.5) 72:28 v/v at flow rate 1 mL/min. TLC was carried out by stationary phase precoated Silica Gel 60 F254 TLC Plate using mobile phase Toluene: Methanol, 8:2 v/v. The UV spectrophotometric determination was performed at 311 nm using solvent methanol. The proposed methods were validated according to ICH Q2-(R1) guidelines. The linearity range for Pirfenidone was 5-70 μg/mL for HPLC, 800-1600 ng/spot for HPTLC and 10-60 μg/mL for UV method. These methods were accurate and precise with recoveries in the range of 98.2-102.32 and relative standard deviation < 2%. The developed methods were successfully applied for determination of Pirfenidone in tablets.

Palavras-chave : UV; HPLC; HPTLC; Pirfenidone; anti-fibrotic agent.

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