Development of Validated RP-HPLC and Analogous UV Spectroscopic Methods for the Analysis of Tofacitinib Citrate
DOI:
https://doi.org/10.22456/2527-2616.148879Keywords:
RP-HPLC, Quality by Design, UV-Spectrophotometry, Tofacitinib citrateAbstract
The current study aims to develop and optimize a simple, novel, reproducible and efficient RP-HPLC and itsanalogous UV spectroscopic method for routine analysis of tofacitinib citrate (TFC). For the RP-HPLC method, chromatographic separations were conducted using a mobile phase comprising acetonitrile and ammonium acetate buffer (55:45%, v/v) at a flow rate of 0.8 mL.min-1. A 32full-factorial design using Design Expert® software was employed for analytical method development in which mobile phase composition and flow rate were chosen as independent variables and the retention time (RT), tailing factor (TF) and theoretical plate count (TP) were selected as responses of the study. Statistically significant models were obtained for the development of the method (p-value <0.05). A UV spectroscopic method was also developed as a representative of the RP-HPLC methodthat can offer comparable results while being more accessible and cost-effective. The developed methods were validated in accordance with ICH Q2(R1) guidelines, demonstrating excellent specificity, linearity (R² > 0.999), accuracy (recovery rates of 98–102%), precision (%RSD < 2%), robustness, ruggedness and system suitability. These results confirm the reliability and suitability of the methods for routine quantification of tofacitinib citrate (TFC) in both pharmaceutical and research settings. Overall, the development of the RP-HPLC method and its corresponding UV spectroscopic method demonstrates a comprehensive approach to the analysis of tofacitinib citrate.
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