Pankaj Bhamare, Rupal Dubey, Neeraj Upmanyu, Pothuvan Umadoss
Pankaj Bhamare, Rupal Dubey*, Neeraj Upmanyu, Pothuvan Umadoss
School of Pharmacy and Research, People’s University, Bhanpur, Bhopal, M.P. 462037, India.
Volume - 11,
Issue - 1,
Year - 2021
Brivaracetam is a racetam derivative of levetiracetam having prominent activity against epilepsy. Objective of the proposed work was to develop and validate a new In-Vitro dissolution methodology for quantitation of % Brivaracetam release fromtablets using HPLC analysis. No official HPLC method has been published yet for the dissolution study of Brivaracetam. All the dissolution parameters have been optimized for quantitation purpose. Initially, 900ml of 0.05M Potassium dihydrogen phosphate buffer (pH 6.4) has taken as a dissolution medium, using a paddle apparatus operated at 75rpm for 45 minutes. Chromatographic analysis has been carried out on C18 column (Inertsil ODS 3V HPLC Column having dimensions of150mm x 4.6mm, 5µm), isocratic analysishas been conductedwith mobile phase containing a mixture of 0.1%v/v trifluoroacetic acid in water and acetonitrile (60:40 v/v) at a flow rate of 1.0mL/min with the elution monitored at wavelength of 210 nm and column oven temperature of 30°C. The method was further validated to meet the requirements of regulator. The dissolution method of analysis developed was adequate for its purpose and could be employed for the routine quality control of Brivaracetam tablets.
Cite this article:
Pankaj Bhamare, Rupal Dubey, Neeraj Upmanyu, Pothuvan Umadoss. A simple HPLC Method for In-Vitro Dissolution study of Brivaracetam in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2021; 11(1):1-8. doi: 10.5958/2231-5675.2021.00001.6
1. Drugbank: Brivaracetam [Internet] Available from source: https://www.drugbank.ca/drugs/DB05541
2. Briviact FDA Approval [Internet] Available from source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf
3. Mhaske D.V., Mali N.V. HPLC Studies on degradation behaviour of Brivaracetam and development of validated stability-indicating HPLC Assay method. Ijsrm. Human, 2016; 4(3): 43-57.http://ijsrm.humanjournals.com/wp-content/uploads/2016/10/4.N.V-Mali-D-V-Mhaske.pdf
4. Vishweshwar V., Babu J. M. and Muralikrishna R. Development and validation of stability-indicating UPLC method for the determination of brivaracetam, its related impurities and degradation products. Int J Pharm Sci Res 2018; 9(6): 2315-2327. https://doi.org/10.13040/IJPSR.0975-8232.9(6).2315-27
5. Vasanth D.A., Rajkamal B. A validated LC-MS/MS method for pharmacokinetic study of Brivaracetam in healthy rabbits. Int J Pharm Pharm Sci, 2017; 10(2):24-29.https://doi.org/10.22159/ ijpps.2018v10i2.21457
6. Imam Pasha S., Murali Balaram Varanasi, Ibrahim Mohammed. Chromogenic spectrophotometric estimation of Brivaracetam in bulk drug and it’s formulation with FolinCiocalteu reagent. IOSR Journal of Pharm. 2017; 7(12):44-48.http://iosrphr.org/papers/vol7-issue12/H0712014448.pdf
7. Gillard M, Fuks B, Leclercq K, Matagne A. Binding characteristics of brivaracetam, a selective, high affinity SV2A ligand in rat, mouse and human brain: relationship to anti-convulsant properties. Eur J Pharmacol. 2011 August 16; 664 (1-3):36-44.https://doi.org/10.1016/j.ejphar.2011.04.064
8. International Conference on Harmonization Q2 (R1), Validation of analytical procedures: text and methodology, Geneva, (2005). https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf
9. International Conference on Harmonization (ICH). Validation of Analytical Methods: Definitions and Terminology. ICH Q2A. 1994.
10. Bhamare P., Dubey R., Upmanyu N., Natarajan S., Umadoss P. A rapid liquid chromatographic estimation of Brivaracetam and it’s related impurities, Asian J Pharm Res. 2019; 9(2): 14-24. Available from source http://www.ajprjournal.com/view_content.php?quat=9&date=2019&issue=2
11. International Organization for Standardization. Accuracy (Trueness and Precision) of Measurement Methods and Results. ISO/DIS 5725-1 to 5725-3. 1994.
12. Dressman J, Kramer J, Pharmaceutical dissolution Testing, Taylor and Francis Group, LLC, 2005.
13. ICH / CPMP Guidelines Q2B, Validation of Analytical Procedures Methodology, 1996.
14. The United State Pharmacopoeia (USP 27), National Publishing Philadelphia, Asian Edn., 2004, 2622-2624.
15. US FDA, General Principles of Validation, Rockville, MD, Center for Drug Evaluation and Research (CDER), May 1987.
16. US FDA, Guidelines for Submitting Samples and Analytical Data for Method Validation,Rockville, MD, Center for Drugs and Biologics Department of Health and Human Services, Feb. 1987.
17. Rowe RC, Sheskey PJ, Quinn ME, Handbook of Pharmaceutical Excipients, 6th Ed, PhP pharmaceutical press USA, 2009.
18. Pankaj Bhamare, P. Umadoss, Neeraj Upmanyu, Rupal Dubey, “Identification, isolation, structural characterisation, synthesis and In-silico toxicity prediction of the alkaline hydrolytic degradation product of brivaracetam by using LC-PDA, preparative HPLC, LC/HESI/LTQ, FTIR, and 1H NMR, Anal. Methods, 12, 1868-1881, 2020.Available from source https://pubs.rsc.org/en/content/ articlelanding/2020/ay/c9ay02582k#!divAbstract.
19. Hamid Khan,“Analytical Method Development in Pharmaceutical Research: Steps involved in HPLC Method Development’’, Asian J. Pharm. Res. 2017; 7(3): 203-207. DOI: 10.5958/2231-5691.2017.00031.4 Available from source https://asianjpr.com/ AbstractView.aspx?Journal=Asian+Journal+of+Pharmaceutical+Research&PID=2017-7-3-10
20. Dinta Suresh, Ms. Meena Aggarwal, Dr. Achal Srivastava, Dr. Mamta Bhushan Singh, “A Comparative Study to Assess the Knowledge of Caregivers of People with Epilepsy and General Public Regarding Epilepsy and its First- Aid Management’’, Asian J. Nur. Edu. and Research.2017; 7(2): 147-150. DOI: 10.5958/2349-2996.2017.00029.5 Available from source https://ajner.com/AbstractView.aspx?Journal=Asian+Journal+of+Nursing+Education+and+Research&PID=2017-7-2-2
21. Dr. Prof. Janet J, Dr. K.R. Biju, “A Qualitative Study to Assess the Needs and Problems of High School Children with Asthma and Epilepsy’’ Int. J. Adv. Nur. Management 3(1):Jan. - Mar., 2015; Page 01-06 Available from source https://ijanm.com/ AbstractView.aspx?Journal=International+Journal+of+Advances+in+Nursing+Management&PID=2015-3-1-1
22. Parag Jain, Anand Surana, Ravindra Pandey, Shiv Shankar Shukla, “Epilepsy: A Neurological Cramp’’ Res. J. Pharmacology and Pharmacodynamics. 5(1): January – February 2013, 01-05 Available from source https://rjppd.org/AbstractView.aspx?Journal=Research+Journal+of+Pharmacology+and+Pharmacodynamics&PID=2013-5-1-16
23. Emmanuel N Tufon, Ogugua Victor N., AmbeiseUmenjoh M. and Mbi Alice, “Evaluating the Management of Epilepsy in the Ngie Community of the North West Region of Cameroon’’, Res. J. Pharmacology and Pharmacodynamics. 5(4): July– August 2013, 241-243. Available from source https://rjppd.org/ AbstractView.aspx?Journal=Research+Journal+of+Pharmacology+and+Pharmacodynamics&PID=2013-5-4-21
24. Pathan Muzammil Khan, Jha Asha, Pathak Swanand, Jha Rajesh, Khond Sachin, Mujawar Jahir, “Antiepileptic Drug Utilization in Pediatric Patients at a Tertiary Care Rural Teaching Hospital of Central India’’, Res. J. Pharmacology and Pharmacodynamics. 7(1): Jan.-Mar. 2015; Page 05-10 DOI: 10.5958/2321-5836.2015.00002.6, Available from source https://rjppd.org/ AbstractView.aspx?Journal=Research+Journal+of+Pharmacology+and+Pharmacodynamics&PID=2015-7-1-14
25. Jitendra Chimakurthy, Talasila EGK Murthy and Lokesh Upadhyay, “Effect of Curcumin on Sub-Therapeutic Doses of AED’S And LongTerm Memory In Mice Induced GTC Type of Seizures in Rats’’, Res. J. Pharm. and Tech. 1(4): Oct.-Dec. 2008;Page 401-404. Available from source https://rjptonline.org/AbstractView.aspx?Journal=Research+Journal+of+Pharmacy+and+Technology&PID=2008-1-4-77
26. M. Kannadasan, Subal Debnath, Nilesh P. Babre, P. Parameshwar, V.V. Rajesham and Habiburrehman, “Anti-Epileptic Activity of the Hydro-Alcoholic Extract of Erythrina fuscaLour. Bark through Behavioral Studies against the Animal Models of Epilepsy’’, Res. J. Pharm. and Tech. 4(2): February 2011; Page 315-319. Available from source https://rjptonline.org/ AbstractView.aspx?Journal=Research+Journal+of+Pharmacy+and+Technology&PID=2011-4-2-22.
27. Reena Singh, Suvendu Narayan Mishra, Monalisa Jena, “A Comparative study to indentify the Psychosocial adjustment of Patients with Epilepsy and Schizophrenia in a Tertiary Care Teaching Hospital’’, Res. J. Pharm. and Tech. 7(8): August 2014 Page 870-875. Available from source https://rjptonline.org/AbstractView.aspx?Journal=Research+Journal+of+Pharmacy+and+Technology&PID=2014-7-8-20
28. HarikumarRajaguru, Sunil Kumar Prabhakar, “Variational Bayesian Matrix Factorization and Certain Post Classifiers for Classification of Epilepsy from EEG Signals’’, Res. J. Pharm. and Tech. 2016; 9(6):750-754 DOI: 10.5958/0974-360X.2016.00142.6. Available from source https://rjptonline.org/AbstractView.aspx?Journal=Research+Journal+of+Pharmacy+and+Technology&PID=2016-9-6-22
29. Keziya Ann Mammenand S. Sathesh Kumar, “A Prospective Observational Study on Depression in Epileptic Patients’’, Res. J. Pharm. and Tech. 2017; 10(8): 2587-2590. DOI: 10.5958/0974-360X.2017.00459.0. Available from source https://rjptonline.org/ AbstractView.aspx?Journal=Research+Journal+of+Pharmacy+and+Technology&PID=2017-10-8-29