International Journal of Research in Pharmacy and Allied Science

ISSN: 2583-6544   |  Issues per year: Monthly  |   Indexed In: Google Scholar, CORE, ScienceOpen, Researchgate

ISSN:2583-6544

Abstract View

Favipiravir (SARS-CoV-2) degradation impurities: Identification and route of degradation mechanism in the finished solid dosage form using LC/LC-MS method

Author(s): Pathan Najiya Shahnoor*1, Dr. Aejaz Ahmed2, Dr. G. J. Khan.3

Email(s): 1najiyasp@gmail.com

Address: Address Not Available

Published In:   Volume - 2,      Issue - 5,     Year - 2023

DOI: Not Available

 View HTML        View PDF

Please allow Pop-Up for this website to view PDF file.

ABSTRACT:
Many countries have approved the use of favipiravir at full dosage in treating SARS-CoV-2 patients in an emergency. The identification of degradation impurities in favipiravir film-coated tablets was accomplished through the development and validation of a precise, accurate, linear, robust, straightforward, and stability-indicating HPLC method. For the purpose of estimating Favipiravir in the active pharmaceutical ingredient and its tablet dosage form using reverse phase high-performance liquid chromatography, forced degradation studies and stability-indicating techniques were developed. The procedure was carried out using a C18 column (250 X 4.6mm X 4µm) and a 60:40 mobile phase mixture of acetonitrile and orthophosphoric acid. The ultra-violet detector was used to maintain the detection wavelength at 324 nm, allowing the mobile phase to pump at a flow rate of 1 ml/min. To establish a stability indicating method, the favipiravir drug was put through a variety of stress situations in accordance with International Conference of Harmonisation Q1A (R2) guidelines. The medication favipiravir was discovered to be susceptible to peroxide breakdown. Mass spectral studies characterised the impurity peak. Analytical standards including linearity, accuracy, precision, sensitivity, and robustness were met during the method's validation. For the estimation of favipiravir, which indicates its stability indicating behaviour, a quick and sensitive method was developed.

Keywords:

Cite this article:
Favipiravir (SARS-CoV-2) degradation impurities: Identification and route of degradation mechanism in the finished solid dosage form using LC/LC-MS method Pathan Najiya Shahnoor*, Dr. Aejaz Ahmed, Dr. G. J. Khan.


1.      Marzouk, H. M., Rezk, M. R., Gouda, A. S., & Abdel-Megied, A. M. (2022). A novel stability-indicating HPLC-DAD method for determination of favipiravir, a potential antiviral drug for COVID-19 treatment; application to degradation kinetic studies and in-vitro dissolution profiling. Microchemical Journal, 172, 106927.

2.      Balu, P. A., & Paresh, M. S. (2021). Stability-indicating RP HPLC method development for estimation of favipiravir in bulk and pharmaceutical dosage form. World Journal of Pharmaceutical Research, 10(14), 1444– 1465.

3.      Blessy, M. R., Patel, R. D., Prajapati, P. N., & Agrawal, Y. K. (2014). Development of forced degradation and stability indicating studies of drugs-a review. Journal of Pharmaceutical Analysis, 4(3), 159–165. https://doi.org/10.1016/j.jpha.2013.09.003

4.      Nazifa Sabir Ali, S., Mobina, L., Mehfuza, M., Seema, P., Ahmed, A., & Khan, J. G. (2021). Analytical method development and validation and forced degradation stability-indicating studies of favipiravir by RP-HPLC and UV in bulk and pharmaceutical dosage form. Journal of Pharmaceutical Research International, 33, 254–271.

5.      Murthy, M. V., Krishnaiah, C., Srinivas, K., Rao, K. S., Kumar, N. R., & Mukkanti, K. (2013). Development and validation of the RP-UPLC method for the determination of darifenacin hydrobromide, its related compounds, and its degradation products using the design of experiments. Journal of Pharmaceutical and Biomedical Analysis, 72, 40–50.

6.      Saranjit, S., Mahendra, J., Gajanan, M., Harsita, T., Moolchand, K., Neha, P., & Padmaja, S. (2013). Forced degradation studies to assess the stability of drugs and products. Trends in Analytical Chemistry, 49, 71–88.

7.      Pallavi, V., Kamalkishor, D., & G. (2021). Bioanalytical method development and validation for the determination of Favipiravir in spiked human plasma by using RP-HPLC. Journal of Pharmaceutical Research International, 33, 275–281.

8.      Divya Kumar Vemuri, Rambabu Gundla, Naresh Konduru, Ravindra Mallavarapu, Naresh Kumar Katari, Favipiravir (SARS-CoV-2) degradation impurities: Identification and route of degradation mechanism in the finished solid dosage form using LC/LC–MS method. Biomedical Chromatography. 2022;36: e5363. https://doi.org/10.1002/bmc.5363.

9.      West C, Lemasson E, Bertin S, Hennig P, Lesellier E. The interest of achiral-achiral tandem columns for impurity profiling of synthetic drugs with supercritical fluid chromatography. Journal of Chromatography A. 2018;1534(1):161-9.

10.   Zeshan Aqeel, J Preston, Phil Koerner. HPLC Column Screening for Favipiravir on Six Different 100 x 4.6 mm Columns.Phenomenexbreakingwith traditions.2020;1;1-3.

11.  Jyothi and Kavya. Ultraviolet Spectrophotometric Method Development for Estimation of New Antiviral Repurposing Drug Favipiravir.Asian J Pharm Clin. Res.2021;14(7):67-69.

12.  Bulduk İ. HPLC-UV method for quantification of favipiravir in pharmaceutical formulations. ActaChromatogr. 2021;33(3):209-15.

13.  Nadendla R, Abhinandana P. Validated High-Performance Liquid Chromatographic Method for the Quantification of Favipiravir by PDA Detector. (2021). Int. J. Life Sci. Pharma Res. 2021;11(2):181-188.

14.   Baokar S, Mulgund S, Ranpise N. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Vildagliptin and Metformin. Res J Pharm Dos Forms Technol. 2013;5(2):95–8.

15.  Bharti Mittu AC, Chauhan P. Analytical Method Development and Validation: A Concise Review. J Anal Bioanal Tech. 2015;06(01):1-5

 

Related Images:



Recent Images



Assessing Philippine Health Care Coverage Gaps: An Assessment of Accessibility of Public Health Programs in Selected Barangay in Imus, Cavite, Philippines
Isoabsorptive UV Spectrophotometry Method development and validation for simultaneous estimation of Eslicarbazepine Acetate and Carbamazepine
To develop and validate the stability indicating method for repaglinide and voglibose using HPLC method
To develop and validate the stability indicating method for Empagliflozin and Linagliptin using HPLC method
A Prospective Observational Study on the Clinical Evaluation of Vertigoin Young Adult Population of Amaravati Capital Region
Quality by Design-Based Analytical Method Development and Validation of Suzetrigine by RP - HPLC
Formulation, Optimization and Evaluation of Rimegepant Pulsatile Tablets for Chronotherapeutic Management of Migraine
Development and Evaluation of Ticagrelor Solid Dispersion Tablets Using PVP K30, PEG 6000 and HPMC E5 for Dissolution Enhancement
To study the effect of various superdisintegrants and binders in the Formulation and Evaluation of Labetalol Rapid Disintegrating Tablet
To Develop and Validate the Stability Indicating Method for Ezetimibe and Rosuvastatin Using HPLC Method

Tags


Quick Links


Latest Issues

Popular Articles