Validated HPTLC Method for the Determination of Nintedanib in Bulk Drug

Abstract

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%.

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

“…Dutta et al. [ 91 ] have developed and validated a stability-indicating method using LC-IT-MS n for the determination of nintedanib in bulk drug. The proposed structure of nintedanib degradant products was elucidated, and a predicted fragmentation pattern was established.…”

Spectrophotometric Investigations of Charge Transfer Complexes of Tyrosine Kinase Inhibitors with Iodine as a σ-Electron Acceptor: Application to Development of Universal High-Throughput Microwell Assay for Their Determination in Pharmaceutical Formulations

“…An appropriate analytical method is needed for TKI quality control (QC). Chromatographic methods including high-performance liquid chromatography (HPLC) [18][19][20][21][22][23] and high-performance thinlayer chromatography (HPTLC) [24][25][26][27] as well as other techniques such as voltammetry [28], spectrofluorimetry [29][30][31][32], and spectrophotometry [33][34][35][36][37][38][39][40][41][42][43][44] have all been reported as methodologies for the QC of TKIs in pharmaceutical formulations. Because of its simplicity, low cost, and widespread availability in QC laboratories, spectrophotometry is the most practical analytical method.…”

Development of Green and High Throughput Microplate Reader-Assisted Universal Microwell Spectrophotometric Assay for Direct Determination of Tyrosine Kinase Inhibitors in Their Pharmaceutical Formulations Irrespective the Diversity of Their Chemical Structures

“…To ensure the accurate contents of TKIs in the formulations, a proper quantitative analytical technique is required. The analytical techniques existing in the literature for the quantitative determination of TKIs in their formulations are chromatography [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ], voltammetry [ 28 ], spectrofluorometry [ 29 , 30 , 31 , 32 ], and spectrophotometry [ 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ]. Among these techniques, spectrophotometry is the most convenient and widely applied technique, as evident from the number of publications [ 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ].…”