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Validated HPTLC Method for the Determination of Nintedanib in Bulk Drug

Birla Institute of Technology, Mesra, Ranchi, Jharkhand 835215, India
Bristol Myers Squibb, E. City Phase—I, Bengaluru, Karnataka 560100, India
Author to whom correspondence should be addressed.
Presented at the 22nd International Electronic Conference on Synthetic Organic Chemistry, 15 November– 15 December 2018; Available Online:
Proceedings 2019, 9(1), 22;
Published: 14 November 2018
PDF [268 KB, uploaded 20 March 2019]


A simple, rapid, precise and accurate High-Performance Thin Layer Chromatography (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 Thin Layer Chromatography (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 Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found to be 83.357 ng/band and 252.599 ng/band respectively. The method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH Q2(R1)] guideline. The method was precise and accurate with %RSD 0.5323 (intraday) and 0.6939 (interday) respectively and percentage recoveries in the range 99.65–101.43%.
Keywords: Nintedanib; HPTLC; idiopathic pulmonary fibrosis Nintedanib; HPTLC; idiopathic pulmonary fibrosis
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Dutta, D.; Das, S.; Ghosh, M. Validated HPTLC Method for the Determination of Nintedanib in Bulk Drug. Proceedings 2019, 9, 22.

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