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Experimental Design Approach by Using Rhplc for the Determination of Rufinamide Assay in Dose Proportional Tablet Rufinamide Tablets 200 Mg
Corresponding Author(s) : L. Saikiran Goud
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
A rapid high performance liquid dosage form. A Kromasil C118, 125 X 4.0 mm, 5µm or or equivalent in isocratic mode, with mobile phase containing a mixture of Weight and transfer about 2.72 of Potassium Di hydrogen phosphate into a beaker containing 1000ml of water, and filter through 0.45µ nylon membrane filter, mobile phase Thoroughly mix buffer, methanol and tetrahydrofuran in the ratio of 80: 15:05 % v/v and Prepare a degasses mixture of water, methanol and acetonitrile in the ratio of 10:50:40 % v/v, The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluents were monitored at 210 nm. The selected chromatographic conditions were found to effectively separator (Rt: 8.98 min) having a resolution of 5.87. The method was validated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantitation. Linearity for were found okay respectively. The percentage recoveries for ranged from 99.97-100.0%, respectively. The limit of detection and the limit of quantitation for was found to be 1.5 μg/ml and 3.0 μg/ml, respectively. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations. The method gives resolution with a short analysis time (< 30 min). The method parameter was validated and establish to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore, the planned method can be used for routine analysis of in medical dosage form.
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- Kim SH, Kang HC, Lee JS, Kim HD. Rufinamide efficacy and safety in children aged 1-4 years with Lennox-Gastaut syndrome. Brain Dev. 2018;40:897–903. [PubMed] [Google Scholar]
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- Perucca E, Cloyd J, Critchley D, Fuseau E. Rufinamide: clinical pharmacokinetics and concentration-response relationships in patients with epilepsy. Epilepsia. 2008;49:1123–1141. [PubMed] [Google Scholar]
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References
Kim SH, Kang HC, Lee JS, Kim HD. Rufinamide efficacy and safety in children aged 1-4 years with Lennox-Gastaut syndrome. Brain Dev. 2018;40:897–903. [PubMed] [Google Scholar]
Saydam M, Takka S. Bioavailability file: rufinamide. FABAD J Pharm Sci. 2019;44:231–242. [Google Scholar]
Wheless JW, Vazquez B. Rufinamide: a novel broad-spectrum antiepileptic drug. Epilepsy Curr. 2010;10:1–6. [PMC free article] [PubMed] [Google Scholar]
Cheng-Hakimian A, Anderson GD, Miller JW. Rufinamide: pharmacology, clinical trials, and role in clinical practice. Int J Clin Pract. 2006;60:1497–1501. [PubMed] [Google Scholar]
Kluger G, Glauser T, Krauss G, Seeruthun R, Perdomo C, Arroyo S. Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study. Acta Neurol Scand. 2010;122:202–208. [PubMed] [Google Scholar]
Wisniewski CS. Rufinamide: a new antiepileptic medication for the treatment of seizures associated with lennox-gastaut syndrome. Ann Pharmacother. 2010;44:658–667. [PubMed] [Google Scholar]
The Merck Index. Merck Research Laboratories, 14th edition, (Monograph #3635), 2006; 621. [Internet]
SC Sweetman (Editor); Martindale. The Complete Drug Reference, 36th edition, The Pharmaceutical Press; London, UK: 2009; 367. [Internet]
McLean AW, Schmutz M, Pozza F. The influence of rufinamide on sodium currents and action potential firing in rodent neurons. Epilepsia. 2005;46:296. [Google Scholar]
Perucca E, Cloyd J, Critchley D, Fuseau E. Rufinamide: clinical pharmacokinetics and concentration-response relationships in patients with epilepsy. Epilepsia. 2008;49:1123–1141. [PubMed] [Google Scholar]
Brunner LA, Powell ML. An automated method for the determination of a new potential antiepileptic agent (CGP 33101) in human plasma using high performance liquid chromatography. Biomed Chromatogr. 1992;6:278–282. [PubMed] [Google Scholar]
Rouan MC, Buffet C, Masson L, Marfil F, Humbert H, Maurer G. Practice of solid-phase extraction and protein precipitation in the 96-well format combined with high-performance liquid chromatography-ultraviolet detection for the analysis of drugs in plasma and brain. J Chromatogr B Biomed Sci Appl. 2001;754:45–55. [PubMed] [Google Scholar]
la Marca G, Malvagia S, Filippi L, Innocenti M, Rosati A, Falchi M, Pellacani S, Moneti G, Guerrini R. Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method. J Pharm Biomed Anal. 2011;54:192–197. [PubMed] [Google Scholar]
Annapurna MM, Kumar BSP, Goutam SVS, Srinivas L. Stability indicating liquid chromatographic method for the quantitative determination of rufinamide in pharmaceutical dosage forms. J Drug Deliv Ther. 2012;2:167–174. [Google Scholar]
Annapurna M, Saketha CN, Pavani S. New stability indicating liquid chromatographic method for the quantitative determination of rufinamide in presence of degredant products. Drug Invent. Today. 2012;4:501–506. [Google Scholar]
Singh J, Sangwan S, Grover P, Mehta L, Kiran D, Goyal A. Analytical method development and validation for assay of rufinamide drug. J. Pharm. Technol. Res. Managem. 2013;1:191–203. [Google Scholar]
Sai Pavan Kumar B, Mathrusri Annapurna M, Pavani S. Development and validation of a stability indicating RP-HPLC method for the determination of rufinamide. J Pharm Anal. 2013;3:66–70.