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This review highlights analytical methods for assessing upadacitinib hemihydrate in ulcerative colitis, suggesting improved quality control and stability testing techniques.
Upadacitinib hemihydrate is a selective Janus kinase-1 (JAK1) inhibitor approved for the treatment of immune-mediated inflammatory diseases, including ulcerative colitis. Due to its oral administration, favorable pharmacokinetics, and targeted action, it is an effective option for patients with moderate to severe disease. Reliable analytical methods are essential for its quality control, stability testing, pharmacokinetic studies, and therapeutic monitoring in bulk drugs, dosage forms, and biological samples. This review summarizes its key properties and highlights reported analytical techniques—mainly HPLC, UPLC, and LC-MS/MS—emphasizing the need for sensitive and validated methods for routine and stability analysis.
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Meshwa Patel*, Dr. Khushbu Patel, Dr. C. N. Patel, Mrs. Sushila R. Prajapati, Aachal Bhavsar, Jinal Goswami (2026) studied this question.
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