Development and validation of simple, rapid and sensitive uv, hplc and hptlc methods for the estimation of pirfenidone in tablet dosage form

• S. G THORAT ^[1] ; S. P PADMANE ^[1] ; M. R TAJNE ^[2] ; A. M ITTADWAR ^[1]
  1. [1] Gurunanak College of Pharmacy Department of Pharmaceutical Chemistry
  2. [2] Rashtrasant Tukadoji Maharaj Nagpur University Department of Pharmaceutical Sciences
• Localización: Journal of the Chilean Chemical Society (Boletín de la Sociedad Chilena de Química), ISSN-e 0717-6309, ISSN 0366-1644, Vol. 61, Nº. 2, 2016, págs. 2978-2981
• Idioma: inglés
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• Resumen

  • 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.