Development And Validation of UV-Spectrophotometric Method for Determination of Upadacitinib Bulk and in Tablet Dosage Form
Abstract
Upadacitinib is a selective Janus kinase-1 (JAK1) inhibitor widely used in the treatment of autoimmune disorders such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, and Crohn's disease. Owing to its therapeutic significance, the development of a simple, accurate, and reliable analytical method for its quantitative estimation is essential for routine quality control. The present study was undertaken to develop and validate a UV-visible spectrophotometric method for the determination of Upadacitinib in bulk drug and tablet dosage form. Methanol was selected as the solvent for the preparation of standard and sample solutions. The absorption spectrum of Upadacitinib was recorded in the ultraviolet region, and the wavelength corresponding to maximum absorbance (λmax) was selected for quantitative analysis. The developed method obeyed Beer-Lambert's law over the concentration range of 2-12 μg/mL, exhibiting excellent linearity with a correlation coefficient (R²) greater than 0.999. The proposed analytical method was validated according to the International Council for Harmonisation (ICH Q2(R2)) guidelines with respect to linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantitation (LOQ). The percentage recovery obtained from accuracy studies was within the acceptable range of 98-102%, while the percentage relative standard deviation (%RSD) for precision studies was found to be less than 2%, indicating good reproducibility and precision. The developed method was successfully applied to the assay of commercial tablet formulations without interference from formulation excipients. The results demonstrated that the proposed UV spectrophotometric method is simple, sensitive, rapid, economical, and suitable for the routine quantitative estimation and quality control analysis of Upadacitinib in bulk drug and pharmaceutical tablet dosage forms.
Keywords: Upadacitinib, UV Spectrophotometry, Method Development, Method Validation, Tablet Dosage Form.
Keywords:
Upadacitinib, UV Spectrophotometry, Method Development, Method Validation, Tablet Dosage FormDOI
https://doi.org/10.22270/jddt.v16i7.7875References
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