VALIDATED HPTLC METHOD FOR THE DETERMINATION OF NINTEDANIB IN BULK DRUG

A simple, rapid, precise and accurate HPTLC method was developed and validated for the estimation of Nintedanib, a novel tyrosine kinase inhibitor used in idiopathic pulmonary fibrosis, in bulk drug. Chromatography was carried out using silica gel 60 F₂₅₄ TLC plate and mobile phase Chloroform: Methanol in the ratio 7:3 v/v. The densitometric determination was done at 386 nm. Regression analysis data for the calibration plot were indicative of a good linear relationship between response and concentration over the range of 800-3200 ng/band. The variance (r) was found to be 0.999. The LOD & LOQ were found to be 83.357 ng/band & 252.599 ng/band respectively. The method was validated according to ICH Q2R1 guideline. The method was precise and accurate with %RSD 0.5323 (intraday) and 0.6939 (interday) respectively and percentage recoveries in the range 99.6459 % – 101.4298 %.