A Novel Stability Indicating Chromatographic Method Development And Validation For The Quantification of Tofacitinib In Pure And Its Dosage Form
Journal Title: IOSR Journal of Applied Chemistry (IOSR-JAC) - Year 2018, Vol 11, Issue 2
Abstract
The present study was focused to develop a novel, selective, reliable and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method for the detection and quantification of Tofacitinib in pure form as well as in its dosage form. The chromatographic method was carried out using isocratic elution programme on C18 Phenomenex Luna (250 x 4.6 mm x 5μm) column with a mobile phase proportion of water and Methanol in the ratio of 50:50 (% v/v). The flow rate was set to 1.0 ml/min with 20 μl injection volume. The eluted components were monitored at 254 nm and ambient column oven temperature was maintained. The developed analytical method was validated according to the ICH guidelines. The developed method was also subjected to various stress conditions like acidic and alkaline hydrolysis, oxidation, photolysis and thermal degradation. The method showed linearity across the concentration range of 10- 60 μg/ml. Limit of detection and quantification was found to be 1.45 and 4.40 µg/ml respectively. The developed method is specific, precise, accurate, robust and stability indicating which can be successfully applied for routine analysis, quality control analysis and also suitable for stability analysis of assay of Tofacitinib in pure form and its formulation as per the regulatory requirements.
Authors and Affiliations
Prathyusha Naik C. N, K. B. Chandra Sekhar
Keywords
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- EP ID EP413993
- DOI 10.9790/5736-1102033337.
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