Development of a Validated Reverse Phase Liquid Chromatographic Assay- Method for Determination of Tofacitinib in Pure form and in Physical Admixtures

Aim: The aim is to develop simple validated analytical method for analysis of Tofacitinib by RP HPLC in pure and laboratory prepared physical admixtures. Method: Tofacitinib was estimated by RP HPLC using methanol , water mixture as mobile phase. Linearity range was found to be 10-50 mcg/ml. The correlation coefficient was 0.9998. The limit of detection and quantification were found to be 0.053 and 1.63 μg /ml respectively. The drug solutions were scanned in UV spectrophotometry and the maximum absorption was found to be 285.9 nm and the same was fixed as detecting lambda by RP HPLC method. The Column used was C₁₈.with the dimensions of 150 mm X 4.6 mm and 5 micron particles. Results and Conclusions: The proposed method was successfully applied for the determination of tofacitinib in pure and laboratory prepared physical mixtures. The % RSD value of Tofacitinib in bulk and physical admixture was calculated at different time intervals for recovery , precision (Iintraday and Interday experiments) and quantification studies were found to be less than 2 %.