ISSN : 2663-2187

DEVELOPMENT AND VALIDATION OF NOVEL RP HPLC METHOD FOR THE ESTIMATION OF BARICITINIB

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Dr. K. Bhavya Sri, Md. Saba Fatima, DhilliRao Gorja, Dr. M. Sumakanth
» doi: 10.48047/AFJBS.6.12.2024. 210-215

Abstract

A novel medication called Baricitinib was licensed to treat severe alopecia areata and moderate to severe rheumatoid arthritis. In 2022, it was also approved by the FDA as the first immunomodulatory medication for the treatment of COVID 19 in hospitalized people who needed extra oxygen. It is a reversible inhibitor of JAK that is selective for J AK 1 , and J AK 2. A straightforward, accurate, cost effective approach has been devised for the estimat ion of Baricitinib in both bulk and tablet fo rmulation . Methanol was used as the diluent in the development of this HPLC technique. The stock solution was prepared using methanol, 10 mg of the pure drug was dissolved in 2 3 ml of methanol, which was then made up of the same. Methanol was used to prepare the dilutions that followed, and the dilutions were measured at 249nm. The approach was verified in compliance with ICH criteria Q2 R(1). The linearity was determined to be between 10μg/mL and 80μg/mL in concentration, with a correlation coefficient (r2) of 0.999. A ccuracy was determined to be within a llowable bounds (%RSD < 2.0). As a result, the technique created is accurate, repeatable, sensitive, and suitable for routine Baricitinib quality control examination.

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