E-ISSN 2229-7723 | ISSN 0976-9234
 

Original Article 


Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples

Ravikanth Inturi, Medepalli David Raju, Mandava Venkata Basaveswara Rao, Srikanth Inturi.

Abstract
Aim: Upadacitinib (UDC) is a potent, orally active and selective Janus kinase-1 inhibitor. Upadacitinib is used in development for the treatment of several autoimmune disorders. In the present investigation, a rapid, specific, selective and novel method has been optimized for evaluation of Upadacitinib in plasma using Methotrexate (MTX) as an internal standard by LC-MS/MS.
Methods: The Upadacitinib and Methotrexate extracted from rat plasma using liquid-liquid extraction method using tert-Butyl methyl ether as extraction solvent. The principle analytes were eluted with the conditions of mobile phase having the 0.1% Formic acid : Acetonitrile (20:80%, v/v) using the Eclipse Plus C18, 4.6 mm × 150 mm, (5 μm) analytical column with the 0.6 ml/min flow rate and 10 µl sample volume using CEM array detector. The retention times of Upadacitinib and Methotrexate were 1.65±0.05 min 0.58±0.05 min with the total run time of 4 min. The curve indicates correlation coefficient (r2) was superior by having the value nearer to 1.0 with linear range of 10.0 n.g/m.l to 500.0 n.g/m.l
Results: The correlation coefficient (r2) for Upadacitinib was found 0.999. The LOQ and LOD for the Upadacitinib found 1.03 n.g/m.l and 0.34 n.g/m.l
Conclusion: The method was validated to comply with the United States Food and Drug Administration (FDA) rules by evaluating system suitability, specificity, sensitivity, linearity, precision, precision, roughness, and stability. The verification parameter results were found to be within acceptable limits. Thus the method which has been originally developed should be used for routine Upadacitinib measurement in plasma samples.

Key words: Upadacitinib, Methotrexate, Plasma, FDA, Bio-analytical, LC-MS/MS.


 
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How to Cite this Article
Pubmed Style

RI, Raju MD, Rao MVB, Inturi S. Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. PNR. 2022; 13(2): 102-107. doi:10.47750/pnr.2022.13.02.016


Web Style

RI, Raju MD, Rao MVB, Inturi S. Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. https://www.pnrjournal.com/?mno=25167 [Access: August 11, 2022]. doi:10.47750/pnr.2022.13.02.016


AMA (American Medical Association) Style

RI, Raju MD, Rao MVB, Inturi S. Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. PNR. 2022; 13(2): 102-107. doi:10.47750/pnr.2022.13.02.016



Vancouver/ICMJE Style

RI, Raju MD, Rao MVB, Inturi S. Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. PNR. (2022), [cited August 11, 2022]; 13(2): 102-107. doi:10.47750/pnr.2022.13.02.016



Harvard Style

, R. I., Raju, . M. D., Rao, . M. V. B. & Inturi, . S. (2022) Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. PNR, 13 (2), 102-107. doi:10.47750/pnr.2022.13.02.016



Turabian Style

, Ravikanth Inturi, Medepalli David Raju, Mandava Venkata Basaveswara Rao, and Srikanth Inturi. 2022. Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. Journal of Pharmaceutical Negative Results, 13 (2), 102-107. doi:10.47750/pnr.2022.13.02.016



Chicago Style

, Ravikanth Inturi, Medepalli David Raju, Mandava Venkata Basaveswara Rao, and Srikanth Inturi. "Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples." Journal of Pharmaceutical Negative Results 13 (2022), 102-107. doi:10.47750/pnr.2022.13.02.016



MLA (The Modern Language Association) Style

, Ravikanth Inturi, Medepalli David Raju, Mandava Venkata Basaveswara Rao, and Srikanth Inturi. "Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples." Journal of Pharmaceutical Negative Results 13.2 (2022), 102-107. Print. doi:10.47750/pnr.2022.13.02.016



APA (American Psychological Association) Style

, R. I., Raju, . M. D., Rao, . M. V. B. & Inturi, . S. (2022) Validation of LC-MS/MS method for monitoring of Upadacitinib in Rat plasma samples. Journal of Pharmaceutical Negative Results, 13 (2), 102-107. doi:10.47750/pnr.2022.13.02.016