Development, Validation, and Forced Degradation Evaluation of a Green Stability-indicating RP-HPLC method for Upadacitinib in Bulk and Tablet Dosage Forms
Abstract
Objective: The current study was to develop a simple, rapid, and reliable RP-HPLC method was proposed for the quantification of Upadacitinib in bulk drug and pharmaceutical dosage forms.
Materials & Methods: Separation was achieved on C18 column using ethanol and 10 mM ammonium acetate in 60:40 (v/v) at isocratic flow rate of 0.5 mL/min over 6 min runtime. The method produces sharp and well-resolved peak with 2.8 min retention time. It displays excellent specificity, with no interference from excipients.
Results: System suitability results were within acceptable limits, with tailing factor of 1.03 and 5813 theoretical plates indicates good column efficiency. The method demonstrates high sensitivity, with LOD and LOQ values of 0.025 μg/mL and 0.082 μg/mL, respectively. A strong linear response was noticed over 30-105 μg/mL (r² = 0.9999). Precision was proved with %RSD values of 0.49 (intra-day) and 0.60 (inter-day), while accuracy was observed in the range of 99.38 % to 100.47%. The method remains stable under small deliberate variations proves its robustness and ruggedness. The forced degradation studies show highest degradation under peroxide (8.76%), and acidic (4.75%), while drug remains stable under basic (3.81%) conditions, thermal (5.07%) and photolytic (2.12%) stress. No interference from degradation products was observed proves its stability-indicating capability. The assay was noticed to be 99.12 % and demonstrates suitability for routine quality and stability assessment of Upadacitinib. The sustainability of the method was evaluated with the use of
the AGREE (0.82), and GAPI (4.8E+02), displayed in the center corresponds to the E-factor of 475, meaning that approximately 475 g of waste is generated per gram of analyte analyzed.
Conclusion: Overall, the results demonstrate the ability of the method to maintain a good balance between analysis reliability, environmental effects, and operational convenience.
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