STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NINTEDANIB ESYLATE IN PHARMACEUTICAL DOSAGE FORM

A simple, rapid, precise and accurate High-Performance Thin Layer Chromatography (HPTLC) method was developed and validated for the estimation of Nintedanib esylate, a novel tyrosine kinase inhibitor used in idiopathic pulmonary fibrosis, in bulk drug.HPTLC method was developed for estimation of Nintedanib esylate by using pre-coated silica gel aluminium plate 60F254 (20x20) cm with 250 µm thickness Methanol: Chloroform: Ammonia (6:4:0.1 v/v/v) as a mobile phase.The forced degradation study of Nintedanib esylate includes oxidation, alkali hydrolysis, acid hydrolysis, thermal conditions, and photolytic conditions.According to the degradation study, Nintedanib esylate is stable under hydrolysis, oxidative, thermal, and photolytic conditions but degrades significantly under acidic and alkaline environments.HPTLC method showed linearity from 100-500 ng/band and accuracy (% recovery) was found to be 100.21-100.57% with correlation coefficient 0.9984.The precision was found to be less than 2 % RSD.The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 2.71 ng/band and 8.23 ng/band respectively.The method has been validated as per ICH guidelines.The developed HPTLC method can be applied for the routine analysis in pharmaceutical industry.