A Combine Spectrophotometric and Chromatographic Method Development and Validation of Levetiracetam Bulk And Tablet Dosage Form
DOI:
https://doi.org/10.22270/ajprd.v9i5.1000Keywords:
UV Spectrophotometric Method, HPLC Method, LevetiracetamAbstract
Objective: Objective of the present analytical research work was to develop and validate Spectrophotometric method and High Performance Liquid Chromatographic method (HPLC Method) for the Levetiracetam bulk and tablet dosage form
Methods: A spectrophotometric method and a HPLC method have been developed and validated for estimation of Levetiracetam in bulk.
Method A (UV SPECTROMETRY Method): Methanol was used for the preparation of stock and working standard solutions of the drugs. 400-200nm UV range was used to scanned standard solutions of drugs using UV spectrophotometer. The λmax of Levetiracetam was found to be 220 nm.
Method B (HPLC Method): The HPLC method for Levetiracetam was developed using cosmosil C18 (4.6 mm x 250 mm, particle size: 5 μm), as stationary particle, isocratic mode. Methanol: ACN: Water (60:20:20) pH3 as a mobile phase. The mobile phase was maintained at a flow rate of 1 ml / min and the detection was carried out at 220 nm. Both the methods were validated according to the ICH guidelines.
Results: Levetiracetam was found to be linear in the concentration range of 10-50 µg/ml for spectrophotometric and HPLC method. Retention time was found to be 4.5 min for Levetiracetam.
Interpretation and Conclusion: Results of validation study were found to be satisfactory. So, the methods can be successfully applied for the routine analysis of Levetiracetam.
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2. Beckett AH and Stenlake JB. Practical Pharmaceutical Chemistry, Part-II, 4th Ed., New Dehli; CBS Publishers and Distributors, 2004; 85- 174.
3. Willard HH, Merrist LL, Dean AJ, Frank A and Settle AF. Instrumental Methods of Analysis, 7th Ed., New Dehli; CBS Publishers and Distributors, 1986; 2-3, 585-587
4. Skoog DA, Holler FJ and Nieman TA. Principle of Instrumental Analysis, 5th Ed., Thomson Publication Limited, London, 2004; 103.
5. Sethi PD., High Performance Liquid Chromatography, Quantitative Analysis of Pharmaceutical Formulations, 1st edition, New Delhi; CBS Publishers and Distributors, 2001; 3-11, 116-120.
6. Toomula N, Kumar A, Kumar S, Bheemidi VS. Development and Validation of Analytical Methods for Pharmaceuticals & Bioanalytical Techniques, 2011; 2(5): 1-4.
7. Lakshmi SRP. A Review on Chromatography with High Performance Liquid Chromatography (HPLC) and its Functions. Research and Reviews: Journal of Pharmaceutical Analysis, March 2015; 4(1): 1-15.
8. Swartz ME. HPLC: An introduction and review. J Liq Chromatogr Rel Technol. 2005;25:1253–63.
9. Sabyasachi Biswal1 , Sumanta Mondal, A New Stability Indicating High Performance Liquid Chromatography Method for the Estimation of Levetiracetam in Bulk and Tablet Dosage Form, Pharmaceutical Methods, Vol 10, Issue 2, Jul-Dec, 2019.
10. Alessandro Di Michele , Aurélie Schoubben, Improved Achiral and Chiral HPLC-UV Analysis of Levetiracetam in Two Different Drug Formulations, Separations 2020, 7, 47.
11. P.V.V. Satyanarayana, Alavala Siva Madhavi, a novel rp-hplc method for the quantification of levetiracetam in formulations, Jamonline / 2(2); 2012 / 223–231.
12. Shine sudev, Dr. Sree Janardhanan.V, Review on HPLC Method Development Validation and Optimization, Int. J. Pharm. Sci. Rev. Res., 56(2), May - June 2019; Article No. 05, Pages: 28-43.
13. Bhoomi P. Shah, Suresh Jain, stability indicating hplc method development: a review, ijpsr, 2012; Vol. 3(9): 2978-2988.
14. Yadav Vidushi, Bharkatiya Meenakshi, a review on hplc method development and validation, rjlbpcs, 2017 March- April, 2(6) Page No.166-178
15. https://go.drugbank.com/drugs/DB08877
16. https://pubchem.ncbi.nlm.nih.gov/compound/Levetiracetam
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