Abstract

Stability Indicating HPTLC Method for Determination of Tofacitinib Citrate

Author(s): Thakariya NV, Ezhava SB

Tofacitinib is a drug of the Janus kinase (JAK) inhibitor class. It is currently approved for the treatment of Rheumatoid Arthritis (RA) in the United States and other countries. A sensitive, selective, precise and stability-indicating High Performance Thin Layer Chromatography (HPTLC) method for quantitative analysis of tofacitinib citrate drug has been established and validated. Chromatographic separation was performed on aluminum plates precoated with silica gel and the mobile phase Chloroform: Methanol (9.5:0.5, v/v). Analysis of tofacitinib citrate was performed in absorbance mode at 287 nm. This system gave compact bands for tofacitinib citrate chromatogram of standard tofacitinib citrate (Rf=0.47 ± 0.03). Tofacitinib citrate was subjected to acid hydrolysis, base hydrolysis, neutral hydrolysis, oxidation, photolysis, dry heat induced degradation: Thermal degradation. The degradation products were well resolved from the pure drug. The linearity was obtained in the range 500-900 ng/spot with correlation coefficients (r2=0.9974) for tofacitinib citrate. The developed technique is precise, specific and accurate. Statistical analysis proves that the method is suitable for the analysis of tofacitinib citrate as bulk drug without any interference from the degradation products. It was concluded that the developed method offered several advantages such as rapid, cost effective, simple mobile phase and sample preparation steps and improved sensitivity made it specific, reliable and easily reproducible in any quality control set-up providing all the parameters are followed accurately for its intended use.

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