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Pharmaceutical Sciences and Drug Design

2022 Volume 2

Development and Validation of a Stability-Indicating UV Spectroscopic Method for Baricitinib in Bulk and Formulation


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  1. Department of Pharmaceutical Analysis, HOD of Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India.
  2. Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India.
  3. Department of Pharmaceutical Chemistry, Principal at RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India.
Abstract

Baricitinib is a novel therapeutic agent recently approved for the treatment of moderate to severe rheumatoid arthritis, severe alopecia areata, and since 2022, COVID-19 in hospitalized adults requiring supplemental oxygen. This drug acts as a selective inhibitor of Janus kinase 1 and 2. This study aimed to establish and validate a stability-indicating UV spectroscopic method for the measurement of baricitinib in both bulk and formulated forms. A straightforward, precise, and cost-effective UV method was developed using dimethylformamide (DMF) and distilled water as the solvent. To prepare the standard stock solution, 10 mg of baricitinib was dissolved in 1 mL of DMF and then diluted with distilled water. Subsequent dilutions were prepared using distilled water and analyzed at a wavelength of 309 nm. The validation of this method was performed according to ICH Q2 R(2) guidelines. The method demonstrated linearity in the concentration range of 10-100 μg/mL with an excellent correlation coefficient (r² = 0.999). The precision results were within the acceptable range, and the % RSD was less than 2.0. Therefore, this developed method is reliable, sensitive, and reproducible, making it suitable for routine quality control analysis of baricitinib.


How to cite this article
Vancouver
Sri KB, Fatima MS, Sumakanth M. Development and Validation of a Stability-Indicating UV Spectroscopic Method for Baricitinib in Bulk and Formulation. Pharm Sci Drug Des. 2022;2:8-13. https://doi.org/10.51847/JxHXkcB6tD
APA
Sri, K. B., Fatima, M. S., & Sumakanth, M. (2022). Development and Validation of a Stability-Indicating UV Spectroscopic Method for Baricitinib in Bulk and Formulation. Pharmaceutical Sciences and Drug Design, 2, 8-13. https://doi.org/10.51847/JxHXkcB6tD

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