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Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF OMBITASVIR, PARITAPREVIR AND RITONAVIR IN TABLET DOSAGE FORMS

Jahnavi Bandla*1, S. Ganapaty2

1Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak-502313, Telangana, India.

2Department of Pharmacognosy and Phytochemistry, GITAM Institute of Pharmacy, GITAM University, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India

ABSTRACT

A specific, stability indicating method was developed and validated for the simultaneous estimation of Ombitasvir, Paritaprevir and Ritonavir in the pharmaceutical dosage form using RP-HPLC. The separation was done using BDS (250mm x 4.6mm, 5µ particle size) column with a mobile phase consisting of ammonium acetate buffer and acetonitrile in the ratio 40:60%v/v on isocratic mode. The mobile phase is pumped into the system at a flow rate of 1.0ml/min. The column oven temperature is maintained at 30ºC. The samples were detected at the wavelength of 257nm. The method was validated as per ICH guidelines. The method was found to be specific, accurate, precise, rugged and robust. The method obeys Beer’s law in the concentration range of 3.13µg/ml – 18.75µg/ml for Ombitasvir, 12.5µg/ml – 75µg/ml for Paritaprevir and 18.75µg/ml 112.5µg/ml for Ritonavir. The correlation coefficient was found to be 0.9996 for Ombitasvir, 0.9996 for Paritaprevir and 0.9997 for Ritonavir. Forced degradation studies were conducted for the standard drug solutions and found to be stable across various stressed conditions. The developed method can be used for the routine analysis of Ombitasvir, Paritaprevir and Ritonavir in pharmaceutical dosage form.

Keywords: Ombitasvir, Paritaprevir, Ritonavir, Stability indicating, Method development, Validation, RP-HPLC


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