Experimental design approach by using rhplc for the determination of rufinamide assay in dose proportional tablet Rufinamide tablets 200 mg release_jwaur7vk3bglhl4ngttnjuioi4

by L. Saikiran Goud, K. Vamshi Krishna, Mohammad Omar

Published in International journal of allied medical sciences and clinical research by Dr Sriram Publications.

2024   Volume 12, Issue 4, p516-524

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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Date   2024-11-23
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