A UPLC method development and validation study of Upadacitinib and its impurities in extended - release oral tablet dosage forms

CONCLUSION: A fast, isocratic, specific, and reproducible ultra - performance liquid chromatographic method was developed and validated for various parameters according to the ICH Q2 (R1) guidelines studies. Stress studies were conducted exposing the sample dilution to various treatments (acid, alkali, peroxide, HPLC water, heat, and UV light). The degradants were well - separated apart from the peaks of the active substance. The stability indicating nature was observed during the degradation. The optimized method can be applied for the separation and estimation of Upadacitinib and its process - related impurities in pharma sector in tablet dosage forms.PMID:38554818 | DOI:10.1016/j.pharma.2024.03.007
Source: Annales Pharmaceutiques Francaises - Category: Drugs & Pharmacology Authors: Source Type: research