Research Journal of Pharmacy and Technology

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Development and Validation of Stability Indicating Uhplc Method for Simultaneous Estimation of Ombitasvir, Paritaprevir and Ritonavir in Pharmaceutical Dosage Forms


Affiliations
1 Professor, Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur - 522002, A.P, India
2 Research Scholar, Acharya Nagarjuna University, Guntur - 522508, A.P,, India
     

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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.

Keywords

Ombitasvir, Paritaprevir, Ritonavir, UPLC, Stability indicating.
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  • Development and Validation of Stability Indicating Uhplc Method for Simultaneous Estimation of Ombitasvir, Paritaprevir and Ritonavir in Pharmaceutical Dosage Forms

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Authors

Nagaraju Pappula
Professor, Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur - 522002, A.P, India
Divya Narla
Research Scholar, Acharya Nagarjuna University, Guntur - 522508, A.P,, India

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.

Keywords


Ombitasvir, Paritaprevir, Ritonavir, UPLC, Stability indicating.

References