Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Estimation of Tofacitinib in Tofacitinib Tablets Dosage Form

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Authors: Swati Mahajan*, Habiburrahman Shaikh, Dr. Mrunal Shirsat
Cited by: 0

Abstract

Aim: The main purpose of the research work is to develop an effective, sensitive, provident and uncomplicated reverse phase HPLC technique for the estimation of Tofacitinib in Tofacitinib tablets dosage form. Study Design: HPLC based grounded quantification studies. Methodology: Estimation of Tofacitinib in Tofacitinib tablet formulation. The separation was set up by using a stationary phase Kromasil C18 (150 x 4.6 mm, 5µ) and the mobile phase comported of pH 4.0 phosphate buffer and acetonitrile in the rate of (80:20 volume/volume). The flow rate was 1.5 mL/min. Tofacitinib was detected using UV sensor at the wavelength of 215 nm. composed of pH 4.0 phosphate buffer and acetonitrile in the rate of (80:20 volume/volume). The flux rate was 1.5 mL/min. Column temperature 25°C and sample temperature 25°C and injection volume 20µL, performance time was 20 moment. Results And Conclusion: The citified technique was validated for numerous parameter as per ICH guidelines like accuracy, precision, linearity, specificity, system suitability, result stability and robustness. The results attained were within the undertaking criteria. So, it can be concluded that the formulated system is easy, specific, cost-efficient, sustainable, and safe and can be successfully employed for the procedure analysis of Tofacitinib in tab and pharmaceutical dosage forms.

Fields of Study & Subjects

Analytical Methods in Pharmaceuticals Biosimilars and Bioanalytical Methods Analytical Chemistry and Chromatography

Publication details

Journal / source
Zenodo (CERN European Organization for Nuclear Research)
Publication date
2 February 2026