Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

Stability indicating HPLC method for the quantification of tofacitinib citrate and its related substances

Author(s): Sampath Kumar Reddy Govind*, Nagaraju Ch VS, Rajan ST, Eshwaraiah S, Kishore M and Chakravarthy IE

A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Tofacitinib citrate drug substance. The method was optimized using buffer (prepared by dissolving 2.72gr potassium di hydrogen phosphate and 1.0gm of 1-Octane sulphonoic acid sodium salt anhydrous taken in 1000mL milli-Q-water and then pH was adjusted to 5.5 with dilute potassium hydroxide solution) along with Acetonitrile 90:10v/v as mobilephase-A, and Acetonitrile: Buffer in the ratio of 70:30v/v as mobile phase-B. The flow rate was set at 1.0 mL min-1, wavelength at 210nm and the column temperature was maintained at 25°C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) sunlight, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.


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