Development of a green high-performance liquid chromatography method for tofacitinib quantification in pharmaceutical formulations and degradation studies.

ABSTRACT

A new high-performance liquid chromatography (HPLC) method was applied for the quantification of the active substance of tofacitinib. Analysis was performed on a Chromasil 100 C18 (100.0 × 4.0 mm, 3.5 µm) stationary phase. The mobile phase consisted of acetonitrile0.2% phosphoric acid in water (1288, v/v). The prepared sample (20.0 µL) was injected into the system. A detection wavelength of 285.0 nm was chosen for the compound, and the flow rate was 0.8 mL/min. The experiment was completed in 5.0 min. The analysis temperature was set to 40.0°C. The method was evaluated using green chemistry. The method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. For linearity studies calibration curves were constructed in the range of 10.0-200.0 µg/mL. The recovery values were calculated at 97.66% and 105.68%. The method developed for the analysis of the active substance had a short analysis time and was cost-effective. It is an environmentally friendly method due to the mobile phase content used. The technique can be used in laboratory analysis and bioequivalence experiments.