Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

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
     

   Subscribe/Renew Journal


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.
Subscription Login to verify subscription
User
Notifications
Font Size


  • K. Kranthi Kiran, A.Srinivasa Rao, D.Gowri Sankar. Development and validation of new stability indicating RP-HPLC method for the determination of selected combinational antiviral drugs in bulk and pharmaceutical dossage forms. International Journal of Medicinal Chemistry and Analysis. 2017; 7(2):63-73.

  • Nourah Zoman Al-Zoman, Hadir Mohamed Maher and Amal Al-Subaie. Simultaneous determination of newly developed antiviral agents in pharmaceutical formulations by HPLC-DAD. Chemistry Central Journal. 2017; 11(1): 1-8.

  • R. S.C.H. Phani; K. R.S. Prasad; Useni Reddy Mallu New analytical HPLC method development and validation for the simultaneous quantification of paritaprevir ombitasvir and ritonavirin spiked human plasma. Oriental Journal of Chemistry. 2017; 33(5): 2363-2369.

  • Mangamma Kuna and Gowri Sankar Dannana. Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Ombitasvir, Paritaprevir and Ritonavir in Tablet Dosage Form. Asian Journal of Chemistry.2018; 30(6): 1277-1283.

  • Jahnavi Bandla, S. Ganapaty. Stability indicating RP-HPLC method development and validation for the simultaneous determination of ombitasvir, paritaprevir and ritonavir in tablet dosage forms. Asian Journal of Pharmaceutical Education and Research. 2018; 7(1): 90-101.

  • Baje, s. I., jyothi, b., and madhavi, n. RP-HPLC method for simultaneous estimation of ritonavir, ombitasvir and paritaprevir in tablet dosage forms and their stress degradation studies. International Journal of Applied Pharmaceutics. 2019; 11(2): 193-210.

  • Medisetti Pravallika, Dr. Devanaboyina Narendra and Gadi Vijaya Lakshmi. Method development and validation for simultaneous estimation of ritonavir, ombitasvir and paritaprevir by RP-HPLC method. European journal of pharmaceutical and medical research. 2020; 7(7): 849-855.

  • Adel Ehab Ibrahim, Roshdy E. Saraya, Hanaa Saleh, Magda Elhenawee. Development and validation of eco-friendly micellar HPLC and HPTLC densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms. Heliyon 5; 2019: e01518.

  • Hamid Khan, Javed Ali. UHPLC: Applications in Pharmaceutical Analysis. Asian J. Pharm. Ana. 2017; 7(2): 124-131.

  • M.M. Eswarudu, M. Chinna Eswaraiah, K. Prasanna Kumar, K. Sudhakar. Ultra Performance Liquid Chromatography (UPLC): A Preeminent Technique in Pharmaceutical Analysis. Research J. Pharm. and Tech. 5(12): Dec. 2012; Page 1484-1489.

  • Swetha Sri. R, Dr. Bhavya Sri. K, Mounika. Ch. A Review on Comparative study of HPLC and UPLC. Research J. Pharm. and Tech 2020; 13(3):1570-1574.

  • Sarika R. Jadhav, Hemant P. Alhat, Joshi S. V. Development of New RP HPLC Method for the Simultaneous Estimation of Lopinavir and Ritonavir in API and in Tablet Dosage Form. Asian J. Research Chem. 6(6): June 2013; Page 555-559.

  • M.P. Gadhvi, A. Bhandari, B. N. Suhagia, U. H. Desai. Development and Validation of RP-HPLC method for Simultaneous estimation of Atazanavir and Ritonavir in their combined tablet dosage form. Research J. Pharm. and Tech. 6(2): Feb. 2013; Page 200-203.

  • Padmanabh B. Deshpande, Santosh R. Butle. Development and Validation of Stability-Indicating RP-HPLC Method for Determination of Atazanavir and Ritonavir. Research J. Pharm. and Tech. 7(11): Nov. 2014 Page 1231-1236.

  • ICH (2005) ICH Harmonized Tripartite Guidelines Q2(R1): validation of analytical procedures. ICH, Geneva.

  • P. Geetha Bhavani, D. Akila Devi. Development and Validation of Stability Indicating UPLC Method for the Simultaneous Estimation of Drugs in Combined Dosage Forms using Quality by Design Approach. Asian J. Pharm. Ana. 2020; 10(3):158-164.

  • G. Indira Priyadarshini, V. Mounika, G. Anjani, B. Sowmya. Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Tezacaftor and Ivacaftor in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2020; 10(1):19-26.

  • Prabhat Dessai, Pankaj Kapupara. Development of Stability indicating RP-HPLC Method Development and Validation for the Estimation of Lamivudine and Zidovudine in Combined dosage form. Research J. Pharm. and Tech. 2020; 13(10):4909-4915.

  • Sri Datla V.V.S.S.N. Raju, A. Manikandan, S.Venkat Rao. Validation of Simple Isocratic RP-UPLC Method for Glecaprevir and Pibrentasvir determination and its Application in the study of Stress Degradation. Research J. Pharm. and Tech 2019; 12(9):4299-4304.


Abstract Views: 143

PDF Views: 0




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

Abstract Views: 143  |  PDF Views: 0

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