Abstract
Reverse phase high performance liquid chromatography method, for estimation of related substances or chromatographic impurities of Barcitinib was developed and validated. Baricitinib was developed by separating its degradation products on a X-Terra RP18 (150x4.6mm, 5.0 µm) column using 0.1% Tri ethyl amine in water adjusted pH-2.5 with OPA and Acetonitrile in simple gradient at a flow rate 1.0 ml/min. The column effluents were monitored by a photodiode array detector set at 224nm. The method was validated in terms of specificity, linearity, accuracy, precision, detection limit, quantification limit and robustness. Forced degradation of Baricitinib was carried out under acidic, basic, peroxide, reduction, thermal, photo and hydrolysis conditions. The proposed method is validated as per ICH Q2 (R1) guidelines. The proposed method is simple as selected chromatographic conditions are not so difficult to apply in routine analysis for testing the chromatographic impurity of baricitinib.
Highlights
Baricitinib is a drug for the treatment of rheumatoid arthritis 1 being developed by Incyte 2 and Eli Lily 3
Baricitinib is associated with transient and usually mild elevations in serum aminotransferase 12 levels during therapy but has yet to be linked to cases of clinically apparent acute liver injury
Linearity The linearity was observed in the concentration range of 10-150μg/ml for Baricitinib
Summary
Baricitinib is a drug for the treatment of rheumatoid arthritis 1 being developed by Incyte 2 and Eli Lily 3. Baricitinib is an orally bio available inhibitor of Janus kinases and (JAK1/2), with potential anti-inflammatory, immunomodulat ing and antineoplastic 5activities. Baricitinib binds to JAK1/2 activation and leads to the inhibition of the JAK-signal transducers and activators of transcription (STAT) signaling pathway. This decreases the production of inflammatory cytokines 6 and may prevent an inflammatory response. In addition baricitinib may induce apoptosis 7 and haematopoiesis 8 they are unregulated and/or mutated in various tumor 9cell types. Baricitinib is an orally bio available small molecule inhibitor of Janus kinases that is used to treat moderate-to-severe rheumatoid arthritis. Baricitinib is associated with transient and usually mild elevations in serum aminotransferase levels during therapy but has yet to be linked to cases of clinically apparent acute liver injury
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