Akademik Veri Yönetim Sistemi
Separation Science Plus, cilt.8, sa.8, 2025 (ESCI)
The primary purpose of this study is to develop and fully validate a simple, accurate, and sensitive stability-demonstrating ultra-high-performance liquid chromatography method for the concurrent quantification of tofacitinib and its associated compounds in solid dosage formulations for the first time. The method was developed on a reversed-phase column; 10 mM ammonium acetate buffer (pH: 5.0)-acetonitrile (80:20, v/v) mobile phase with an ultraviolet detector at a flow rate of 0.5 mL/min. The wavelength for tofacitinib was determined to be 220 nm. The analysis was completed within 12 min. The linearity ranges obtained for tofacitinib, TF-A impurity, TF-F impurity, and TF-V impurity were 22.0–240.3 ng/mL (r2 = 0.9998), 17.6–602.1 ng/mL (r2 = 0.9996), 101.4–608.2 ng/mL (r2 = 0.9998), and 7.6–604.7 ng/mL (r2 = 0.9997), correspondingly. The limit of detection values for TF-A impurity, TF-F impurity, and TF-V impurity were 6.2, 35.5, and 2.7 mg/mL, respectively. The recoveries for TF-A impurity, TF-F impurity, and TF-V impurity at the limit of quantification level were calculated as 95.6%, 109.0%, and 104.6%, respectively. The established method was validated and successfully applied for the analysis of tablet formulations in solid dosage forms. The method was also evaluated for its selectivity and stability by exposing it to stress conditions such as oxidative, basic, acidic, thermolysis, and photolysis degradation studies. The method enabled rapid and simultaneous determination of tofacitinib and its related impurities in solid dosage forms for the first time, using a precise, accurate, and simple approach that eliminates the need for complex processes such as prior separation or derivatization.