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<p>A sensitive, economical, and eco-friendly stability-indicating RP-HPLC method was established and validated for the quantification of Upadacitinib (UPD), a second-generation selective Janus kinase (JAK) inhibitor, in the presence of its degradation products. Separation was achieved on a COSMOSIL C18 column (250&#xa0;mm × 4.6&#xa0;mm) using a mobile phase of acetonitrile and 0.1% formic acid (60:40, v/v) at a flow rate of 0.8 mL/min, with detection at 290&#xa0;nm. Validation in accordance with ICH guidelines confirmed the method’s specificity, accuracy, precision, robustness, and linearity across the range of 2.5–7.5 ppm (R² = 0.9996). The LOD and LOQ using standard deviation of Y-intercept were found to be 0.298 ppm and 0.905 ppm, respectively. Forced degradation studies showed significant degradation under acidic (15.75%), alkaline (22.14%), and oxidative (11.79%) stress, whereas UPD was stable under thermal and photolytic conditions. The method can be successfully used for stability assessment of UPD in pharmaceutical dosage forms using the area normalization technique. Greenness evaluation through ComplexGAPI, AGREE, and AMGS confirmed the eco-friendly nature of the developed method.</p>

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Development and validation of a green stability-indicating RP-HPLC method for upadacitinib: a selective Janus kinase (JAK) inhibitor

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  • 发表日期：

    2025年9月22日

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  • Arun M. Kashid,
  • Deepali P. Kaldate

摘要

A sensitive, economical, and eco-friendly stability-indicating RP-HPLC method was established and validated for the quantification of Upadacitinib (UPD), a second-generation selective Janus kinase (JAK) inhibitor, in the presence of its degradation products. Separation was achieved on a COSMOSIL C18 column (250 mm × 4.6 mm) using a mobile phase of acetonitrile and 0.1% formic acid (60:40, v/v) at a flow rate of 0.8 mL/min, with detection at 290 nm. Validation in accordance with ICH guidelines confirmed the method’s specificity, accuracy, precision, robustness, and linearity across the range of 2.5–7.5 ppm (R² = 0.9996). The LOD and LOQ using standard deviation of Y-intercept were found to be 0.298 ppm and 0.905 ppm, respectively. Forced degradation studies showed significant degradation under acidic (15.75%), alkaline (22.14%), and oxidative (11.79%) stress, whereas UPD was stable under thermal and photolytic conditions. The method can be successfully used for stability assessment of UPD in pharmaceutical dosage forms using the area normalization technique. Greenness evaluation through ComplexGAPI, AGREE, and AMGS confirmed the eco-friendly nature of the developed method.