METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TOFACITINIB IN TABLET DOSAGE FORM BY USING RP-UHPLC

S. Sravanthi*, Permula Praveen Kumar and Chandrasekhara Rao Baru

ABSTRACT

For Tofacitinib, a novel analytical technique for the UHPLC method was developed, refined, and then used on pharmaceutical dosage forms. To achieve a suitable chromatographic separation, several mobile phase systems were made and employed; however, the suggested mobile phase, which included buffer, acetonitrile, and methanol in the ratio 40:40:20, provided superior sensitivity and resolution. Thermo Scientific's UV detector (4.6mm x 3mm x 5μm) was used to make the detection at 290 nm. In terms of retention durations and theoretical plates, the optimal flow rate for tofacitinib was determined to be 0.7 ml out of the various flow rates that were examined. Tofacitinib has a retention time of 2.129. Tofacitinib's asymmetry factor, also known as the tailing factor, was determined to be 1.4, indicating that the peak is symmetrical. Retention duration, tailing factor, capacity factor, and theoretical plate count were among the system suitability metrics that were computed. Tofacitinib's theoretical plate count was approximately 2210, indicating the column's effective operation. The method's specificity is shown by these factors. Visual examination of the peak area plot as a function of analyte concentration was used to assess the linearity range; the relevant calibration graphs are displayed in the figure, and the results are displayed in the table. The designated concentration range was established based on the linearity studies. Tofacitinib was shown to be linear for the target concentrations between 50% and 150%. System precision and technique precision were used to confirm the validity of the suggested approach. Tofacitinib's system and method precision percentages were tabulated. In order to conduct placebo interference tests, the standard was injected first, followed by the placebo and the standard. At the RT of the analyte peak, they showed no signs of placebo interference. By altering the flow rate and conducting filter validation tests on various filter types, robustness experiments were conducted. The suggested approach was confirmed to be resilient after the analytical data and filter validation results were tabulated. Two analysts and a different system were used to conduct the investigation on ruggedness. The developed method is found to be robust because the results were tabulated and found to be within limitations.

Keywords: Method Development, Validation, Tofacitinib, Tablet Dosage, RP-UHPLC.