Thin layer chromatographic method for separation and estimation of anticancer drug Ibrutinib in presence of its degradants. Issue 8 (13th June 2021) - Shah, Dimal A.
Abstract: A precise, accurate, and sensitive thin‐layer chromatographic method was developed for the estimation of anticancer drug Ibrutinib in synthetic mixture. The developed method uses precoated silica gel 60 F254 aluminum plates as stationary phase and Methanol: Ethyl acetate: Ammonia (2: 8: 0.2, v/v/v) as mobile phase. The densitometric analysis was carried out at the 286 nm under the reflectance mode and R f was found to be 0.60 under optimized chromatographic condition. The linearity of the method was observed in the range of 100–500 ng/band. The developed method was validated as per the ICH guideline for the parameters like linearity, accuracy, precision, robustness, and specificity. As a part of specificity, a forced degradation study was carried out to know the possible amount of degradation under the various stress conditions such as acid, base hydrolysis, and oxidative stress degradation where the drug and the degradants band were well resolved from each other. The proposed method was successfully used for the estimation of IBR in a synthetic mixture.