Development And Validation Of Stability Indicating Rp-Hplc Method For The Quantification Of Amine Impurity In Tofacitinib Tablets Dosage Form

Abstract

Highly sensitive method for the determination of degradation impurity such as Methyl-[(3R,4R)-4-methyl-piperidin-3-yl]-(7H-pyrrolo[2,3-d]pyrimidin-4yl)-amine(Amine impurity) in Tofacitinib  solid dosage form by using RP-HPLC method. Samples are analysed by reverse phase (RP-HPLC) using stationary phase Inert Clone ODS(3)  (250 x 4.6mm, 5µm) column and the mobile phase-A consisted of pH 3.0 phosphate buffer and the mobile phase-B consisted of  Acetonitrile in the proportion of gradient elution. The flow rate is 1.0 mL/min, the column oven was preserved at 40°C and sampler cooler oven was preserved 5°C, injection volume 25 µL and wavelength fixed at 210nm. The established HPLC method was validated with admiration to specificity, precision, linearity, accuracy, LOD, LOQ and solution stability. Validation study compared as stated by ICH instruction.