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 ۸۵:۱۵ v/v ratio in a triethylamine buffer with a pH of ۳.۵. Using a stationary phase column, the separation was accomplished. Waters X-Bridge shield RP-۱۸ (۱۵۰ × ۴.۶ mm, ۵), column temperature and sample temperature were both kept at ambient levels, and the injection volume and runtime were ۲۰ µL and ۱۲ minutes, respectively. The UV detection occurred at ۲۱۵ nm, and the flow rate was ۱.۰ mL/min. Tofacitinib's retention period was shown to be ۷.۲ minutes. ICH guidelines were followed in the method's validation. The accuracy, reproducibility, and consistency of the suggested procedure were discovered.

Keywords:

Tofacitinib Liquid , chromatography Dissolution and Validation