Tofacitinib in Pharmaceutical Solid Dosage from Dissolution Study: Development and Validation of RP-HPLC Method

A simple, sensitive, precise, and accurate reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the dissolution study of Tofacitinib in Tofacitinib tablets dosage form. The mobile phase for the method was made by combining ortho phosphoric acid and acetonitrile in an 85:15 v/v ratio in a triethylamine buffer with a pH of 3.5. Using a stationary phase column, the separation was accomplished. Waters X-Bridge shield RP-18 (150 × 4.6 mm, 5), column temperature and sample temperature were both kept at ambient levels, and the injection volume and runtime were 20 µL and 12 minutes, respectively. The UV detection occurred at 215 nm, and the flow rate was 1.0 mL/min. Tofacitinib’s retention period was shown to be 7.2 minutes. ICH guidelines were followed in the method’s validation. The accuracy, reproducibility, and consistency of the suggested procedure were discovered.