Abstract

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE ESTIMATION OF ABROCITINIB IN TABLET DOSAGE FORM

Shifa Khan*, Shreya Thakker, Prajyot Mali, Vijay Kumar Munipalli, Ashok Kumar, Sachin Palekar

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Abstract

A new, selective, reliable analytical RP-HPLC method for estimating Abrocitinib in solid dosage form was developed and validated. The chromatographic analysis was carried out on a reverse phase analytical column of Inertsil C-18 (250 mm x 4.6 mm, 5μm) column with a mobile phase of Water: Acetonitrile in a 60:40 v/v ratio at a flow rate of 1 ml/min. At a wavelength of 287 nm, the desired analyte was identified without any interference. The retention time of the drug was discovered to be 5.2 minutes. The graphical method produced linear responses with a regression coefficient of 0.9997 for the concentration range of 10-130 μg/ml of. The LOD and LOQ values were 5 and 10 μg/ml, respectively. These results obtained, showed a good agreement with the declared content in that of the formulation. Therefore, the proposed method is rapid, accurate, and validated for the quantification of abrocitinib in solid dosage form.

Keywords: RP-HPLC, Method development, Validation, Abrocitinib.