DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR ESTIMATION OF TOFACITINIB CITRATE IN ITS EXTENDED RELEASE TABLETS

The present study was focused to develop a simple, precise, accurate and cost effective RP-HPLC method for estimation of Tofacitinib from Tofacitinib Citrate extended release tablet dosage form. The chromatographic method was carried out using Inertsil ODS-3V (150 mm × 4.6 mm, 5 µm) column with mobile phase Phosphate buffer (pH 5.5) and Acetonitrile in ratio of 65:35 %v/v. The flow rate was set 1.0 ml/min with 5 µL injection volume. Total run time 7 min. Detection was carried out at the wavelength of 287 nm. The developed analytical method was validated according to the ICH guideline. The Develop method was also subjected to various stress condition like acid and alkali hydrolysis, oxidation, photolysis, humidity and thermal degradation. The detector response was linear in the concentration range of 21.86– 174.94 µg/ml. The developed method is successfully applied for estimation of Tofacitinib from Tofacitinib Citrateextended release tablet dosage form.