ABSTRACT:
Tofacitinib, administered as Tofacitinib citrate, is a member of a novel class of therapeutic agents known as Janus kinase (JAK) inhibitors. It is approved by the US FDA for the treatment of moderate to severe conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. In the present study, a simple and cost-effective UV spectrophotometric method was developed for its analysis. The method primarily utilizes ethanol as an eco-friendly green solvent, with a small quantity of N,N-dimethylformamide as a co-solvent. Method development included verification of compliance with the Beer-Lambert Law, ensuring linearity within the concentration range of 2–20µg/mL, with a correlation coefficient (r²) of 1.000. The maximum absorbance (?max) for the developed method was found to be 249nm. Validation of the method was carried out in accordance with ICH guidelines, confirming that the method is simple, accurate, precise, sensitive, linear, and rugged. The developed method is suitable for both qualitative and quantitative estimation of Tofacitinib citrate in bulk drug as well as pharmaceutical formulations. Percent assay was successfully performed for extended-release tablets and transdermal formulations. The method enables calculation of percent label claim using either a standard solution or a calibration curve. Due to its simplicity, cost-effectiveness, and use of predominantly green solvent, this method is highly suitable for routine analysis of Tofacitinib citrate in pharmaceutical industries and analytical laboratories.
Cite this article:
Sana Tabassum, Dr. Makula Ajitha. Analytical Method Development and Validation of Spectrophotometric Method for Estimation of Tofacitinib citrate in oral and Topical Formulations. Asian Journal of Pharmaceutical Analysis. 2026; 16(3):185-0. doi: 10.52711/2231-5675.2026.00028
Cite(Electronic):
Sana Tabassum, Dr. Makula Ajitha. Analytical Method Development and Validation of Spectrophotometric Method for Estimation of Tofacitinib citrate in oral and Topical Formulations. Asian Journal of Pharmaceutical Analysis. 2026; 16(3):185-0. doi: 10.52711/2231-5675.2026.00028 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-3-4
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