Development and Validation of a Sensitive Spectrofluorimetric Method for the Determination of Ibrutinib

A reproducible, sensitive, and cost-effective spectrofluorimetric method has been developed for quantification of the drug ibrutinib in bulk and in its oral capsule formulation. The method was validated in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines with respect to linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. The method was found to be extremely sensitive, and excellent linearity was noted within the concentration range 0.1-7.5 mu g/mL with a correlation coefficient (r(2)) of 0.9961. The LOD and LOQ values for the proposed method were found to be 0.224 and 0.680 mu g/mL, respectively. Excellent recoveries of the drug were observed from the marketed capsule formulation by the proposed method (97.59, 1.42% relative standard deviation).