Development and Validation of a Stability indicating Related Substances of Baricitinib by RP-HPLC and its Degradation
S. Mohan1, N. Srinivasarao2, K. Lakshmi3
1Dr. Mohan Seelam*, Department of chemistry, Bapatla Engineering College, Bapatla, India.
2Dr. Srinivasa Rao Nathani, Department of chemistry, Bapatla Engineering College,Bapatla, India.
3K.Lakshmi, Department of chemistry, Tirumala Engineering College, Narasarao pet, India.
Manuscript received on October 09, 2019. | Revised Manuscript Received on October 10, 2019. | Manuscript published on October 15, 2019. | PP: 04-09 | Volume-4 Issue-2, October 2019. | Retrieval Number: A0369094119/2019©BEIESP | DOI: 10.35940/ijmh.A0369.104219
Open Access | Ethics and Policies | Cite
© The Authors. Blue Eyes Intelligence Engineering and Sciences Publication (BEIESP). This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
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 (150×4.6mm, 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.
Keywords: Baricitinib, RP-HPLC, Related substances, Chromatographic impurity.