Author(s): Nagaraju Pappula, Divya Narla

Email(s): pappulanagaraju@gmail.com

DOI: 10.52711/0974-360X.2022.00218   

Address: Nagaraju Pappula1*, Divya Narla2
1Professor, Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur - 522002, A.P, India.
2Research Scholar, Acharya Nagarjuna University, Guntur - 522508, A.P, India.
2Aditya College of Pharmacy, Surampalem- 533447, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 3,     Year - 2022


ABSTRACT:
The present research work was aimed to develop a validated UPLC method for simultaneous quantification of Ombitasvir, Paritaprevir and Ritonavir in bulk and pharmaceutical dosage forms. The analytes were successfully separated within 3 mins on waters SB C8 column using pH 4.0 phosphate buffer and acetonitrile in the ratio of 50:50v/v as mobile phase at a flow rate of 0.5ml/min with an injection volume of 0.5µl. The eluted analytes at 0.908, 1.190 and 1.739 min were detected at 250nm by PDA detector. The developed method was validated in compliance with ICH guidelines. The analytes under study obeyed beers law in the concentration range of 3.125 – 18.75µg/ml, 18.75 – 112.5µg/ml and 12.5 - 75µg/ml for Ombitasvir, Paritaprevir and Ritonavir respectively. The percentage recovery of analytes was found to be within 99-101% for the three analytes. The percentage RSD values of precision and robustness were within acceptable limits. The analytes were subjected to various stress conditions such as hydrolysis by acid, alkali and water, oxidation by hydrogen peroxide, exposure to High temperature and UV light, which enables analytes to degrade under these conditions. The proposed method was successful in separating and quantifying the compounds in the presence of degradants. Thus a specific, accurate and robust stability indicating method has been developed for simultaneous quantification of Ombitasvir, Paritaprevir and Ritonavir in their combined dosage form.


Cite this article:
Nagaraju Pappula, Divya Narla. Development and Validation of Stability Indicating UHPLC Method for Simultaneous Estimation of Ombitasvir, Paritaprevir and Ritonavir in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2022; 15(3):1307-2. doi: 10.52711/0974-360X.2022.00218

Cite(Electronic):
Nagaraju Pappula, Divya Narla. Development and Validation of Stability Indicating UHPLC Method for Simultaneous Estimation of Ombitasvir, Paritaprevir and Ritonavir in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2022; 15(3):1307-2. doi: 10.52711/0974-360X.2022.00218   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-3-61


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