Validated HPTLC Method for the Determination of Nintedanib in Bulk Drug†
AbstractA 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%.
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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.
Dutta D, Das S, Ghosh M. Validated HPTLC Method for the Determination of Nintedanib in Bulk Drug. Proceedings. 2019; 9(1):22.Chicago/Turabian Style
Dutta, Debanchal; Das, Soumyajit; Ghosh, Manik. 2019. "Validated HPTLC Method for the Determination of Nintedanib in Bulk Drug." Proceedings 9, no. 1: 22.
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