A Stability, Accuracy, and Robustness Representing Liquid Chromatographic Method for the Quantification of Zanubrutinib and Its Specified Impurities
SUBHASHINI KANTHETI,
R. RAMESH RAJU
Abstract:Objective: An innovative RP-HPLC isocratic method was established and then validated using Zanubrutinib and its specified impurities (Impurity-1, Impurity-2, Impurity-3, Impurity-4, and Impurity-5).
Methods: In this method, effective chromatographic separation was given an X-Bridge Phenyl column measuring 250 mm x 4.6 mm, packed column with 5μ as a particle size. Acetonitrile, 1% Ortho Phosphoric acid (pH: 2.7), and methanol in the volume ratios 40, 40, and 20 were utilized as a mobile phase at room temperatur… Show more
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