Abstract
A STUDY OF METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION FOR SIMULTANEOUS QUANTIFICATION OF GLECAPREVIR AND PIBRENTASVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Dr. G. Alluraiah*, G. Kishore, Dr. Y. Hanumantha Rao and P. Srinivasa Rao

ABSTRACT

Objective: The present paper describes a simple, accurate and precise reversed phase HPLC method for rapid and simultaneous quantification of Glecaprevir and Pibrentasvir in bulk and pharmaceutical dosage form. The chromatographic separation was achieved on Luna C18 (150x4.6mm, 3.5μm). Mobile phase contained a mixture of 0.1% Ortho Phosphoric acid (OPA) and Acetonitrile in the ratio of 50:50 v/v, flow rate 1.0ml/min and UV detection at 258nm. The proposed method shows a good linearity in the concentration range of 10-150 μg/ml for Glecaprevir and 4-60 μg/ml for Pibrentasvir under optimised conditions. Precision and recovery study results are in between 98-102%. In the entire robustness conditions %RSD is below 2.0%. Degradation has minimum effect in stress condition and solutions are stable up to 24 hrs.

Keywords: Glecaprevir and Pibrentasvir.


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