Haramaya University, College of Health and Medical Sciences, School of Pharmacy, Department of Pharmaceutical Chemistry, Harar, Ethiopia
A B S T R A C T
The objective of the current study was to develop and validate a rapid, precise, specific and stability-indicating reverse phase HPLC for the quantitative determination of TOFACITINIB in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form in the presence of degradation products. The drug was subjected to stress conditions of acid, alkali, thermal, photolytic, humidity and peroxide. As per international conference on harmonization (ICH) prescribed stress conditions to show the stability-indicating power of the method. It was found tofacitinib is very sensitive to various stress conditions. The chromatographic conditions were optimized using the samples generated from forced degradation studies. Regression analysis shows r value (correlation coefficient) 0.998 for tofacitinib. The chromatographic separation was achieved on a symmetry C18 stationary phase. The method employed an isocratic elution and the detection wave-length was set at 379 nm. The mobile phases consist of water and methanol delivered at a flow rate of 1.2 mL•min–1. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.
Keywords: Tofacitinib, Forced degradation, Assay, Method Validation, HPLC