Abstract :
Ibrutinib is a first-in-class, orally active Bruton's tyrosine kinase (BTK) inhibitor that has transformed the treatment of various B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), and marginal zone lymphoma (MZL). It works by irreversibly binding to BTK, thereby blocking B-cell receptor (BCR) signaling, which is essential for the proliferation and survival of malignant B-cells. Clinical studies have shown that ibrutinib significantly improves progression-free survival (PFS) and overall response rates (ORR), even in patients with high-risk genetic mutations such as del(17p). Ibrutinib is generally well tolerated, with manageable adverse effects including diarrhea, fatigue, bleeding, atrial fibrillation, and hypertension. However, resistance can develop over time due to mutations in BTK (e.g., C481S) or in downstream signaling proteins, posing challenges to long-term efficacy. To address this, ongoing research is exploring combination therapies and second-generation BTK inhibitors. Ibrutinib marks a significant advancement in targeted cancer therapy by offering an effective and less toxic alternative to conventional chemotherapy, thus improving quality of life and survival in patients with B-cell malignancies. In present Paper diverse approaches for the analysis of Ibrutinib in bulk drug along with its formulations are considered the abnormal proteins that instruct cancer cells to proliferate are stopped. This prevents cancer cells from proliferating. Using a range of analytical methods, such as UV spectroscopy, high performance thin liquid chromatography (HPTLC), high pressure liquid chromatography (HPLC), reversed phase high performance liquid chromatography (RP-HPLC), ultra performance liquid chromatography (UPLC), liquid chromatography-tandem mass spectroscopy (LC-MS/MS), and capillary electrophoresis (CE), it has been possible to identify ibrutinib.
Keyword :
Ibrutinib, HPLC, LC-MS/MS, HPTLC, UPLC, CE