Abstract
Objective: The present work focused on developing a validated stability indicating RP-HPLC method for the estimation of pirfenidone in bulk drug and tablet dosage form.
 Methods: The chromatographic separation was performed on symmetry C18 (150 mm x 4.6, 5 micron) with a 1 ml/min flow rate at 315nm. The mobile phase employed was orthophosphoric acid buffer: acetonitrile (65:35). Column temperature was maintained at 30ºC. Pirfenidone was subjected to different forced degradation conditions according to ICH guidelines, including acid, base and neutral hydrolysis, oxidation, photolysis and thermal degradation. 
 Results: In alkali, acidic, oxidation and UV degradation conditions the drug shows considerable degradation. Pirfenidone was stable under neutral hydrolysis and thermal degradation. Pirfenidone was stable under extreme degradation conditions showing less than 8% of degradation in all degradation conditions. This result showed that pirfenidone was stable under stress degradation. Then the optimized method was validated for the parameters like linearity, accuracy, precision and robustness as per ICH guidelines.
Highlights
Idiopathic pulmonary fibrosis (IPF) is a chronic, fibrosing idiopathic interstitial lung disease (ILD) characterized by progressive scarring of the lung parenchyma associated with a steady worsening of respiratory symptoms, and decline of pulmonary function, leading to death
In order to achieve a well resolved peak of pirfenidone from its stress degradation products the selection of mobile phase and its composition were considered as prime factors
The forced degradation method was obvious for the stable nature of pirfenidone even under extreme degradation conditions
Summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, fibrosing idiopathic interstitial lung disease (ILD) characterized by progressive scarring of the lung parenchyma associated with a steady worsening of respiratory symptoms, and decline of pulmonary function, leading to death. Two antifibrotic agents are available: pirfenidone and nintedanib. Pirfenidone has proven anti-inflammatory and antifibrotic effects [1]. The studies demonstrated that pirfenidone reduces the decline of forced vital capacity (FVC) in patients with IPF [1]. Purchased from Merck company private limited, Mumbai, India. The pirfenidone active pharmaceutical ingredient was purchased from MSN pharmaceuticals, Hyderabad. The commercial pirfenidone (267 mg) tablets were procured from local market in Hyderabad
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